PROTECTION OF TRADITIONAL KNOWLEDGE, GENETIC RESOURCES AND EXPRESSIONS OF FOLKLORE ACT: INDEX TO SUBSIDIARY LEGISLATION

Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations

PROTECTION OF TRADITIONAL KNOWLEDGE, GENETIC RESOURCES AND EXPRESSIONS OF FOLKLORE REGULATIONS

[Sections 29 and 73]

Arrangement of Regulations

Regulation

PART I
PRELIMINARY

1. Title

2. Interpretation

PART II
APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE

3. Registration of traditional knowledge or expressions of folklore

4. Objection to an application for registration of traditional knowledge or expressions of folklore

5. Request for further particulars

6. Determination of an objection

7. Registration of traditional knowledge or expressions of folklore

8. Certificate of registration

9. Access to registered traditional knowledge or expressions of folklore

10. Application for approval of licensing agreement

PART III
ACCESS TO GENETIC RESOURCES

11. Application for prior informed consent

12. Access permit or exploration permit

PART IV
GENERAL PROVISIONS

13. Access agreement

14. Objection to access agreement

15. Approval or rejection of access agreement

16. Alteration, suspension or termination of access agreement

17. Compulsory licence

18. Appointment of agent

19. Request for information from Register

20. Notification of change of particulars

21. Application for duplicate certificate

22. Application for amendment or correction of document

23. Competent National Authority and National Focal Point

24. Fees

FIRST SCHEDULE

SECOND SCHEDULE

SI 61 of 2021.

PART I
PRELIMINARY

1. Title

These Regulations may be cited as the Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Regulations.

2. Interpretation

In these Regulations, unless the context otherwise requires—

“agent” means a legal practitioner or person registered as a patent agent under the Patents Act, 2016, or a trade mark agent under the Trade Marks Act;

“appropriate institution” has the meaning assigned to the word in the Act;

“certificate of registration” means a certificate of registration issued under regulation 8;

“compulsory licence” means a licence issued under regulation 17;

“counter-statement” means a response to an objection for the registration of traditional knowledge or expressions of folklore;

“holder” has the meaning assigned to the word in the Act;

“licensing agreement” means an agreement concluded by the holder of an expression of folklore to authorise or licence the use of the expression of folklore; and

“Nagoya Protocol” means the Nagoya Protocol on Access and Benefit Sharing which entered into force on 12th October, 2014 and was ratified by Zambia on 20th May, 2016.

PART II
APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE

3. Registration of traditional knowledge or expressions of folklore

(1) A person who intends to register traditional knowledge or expressions of folklore shall apply to the Registrar in Form I set out in the First Schedule on payment of the fee set out in the Second Schedule.

(2) The Registrar shall cause a notice of the application for registration of the traditional knowledge or expressions of folklore in Form II set out in the First Schedule to be published in the Gazette, newspaper of general circulation in the Republic or other media.

4. Objection to application for registration of traditional knowledge or expressions of folklore

(1) A person may, within 60 days of the date of the publication of the notice of the application for traditional knowledge or expressions of folklore, lodge an objection with the Registrar in Form III set out in the First Schedule on payment of the fee set out in the Second Schedule.

(2) The Registrar shall, within 14 days of receipt of an objection made under sub-regulation (1), serve the applicant with a copy of the objection.

(3) An applicant shall, within 30 days of receipt of the objection, lodge with the Registrar a counter-statement in Form IV set out in the First Schedule, stating the grounds relied on in support of the application for registration.

(4) Where an applicant does not lodge the counter-statement under sub-regulation (3), the application shall be deemed to have been abandoned.

5. Request for further particulars

(1) The Registrar may, where the Registrar requires further particulars in relation to an application or an objection, request an applicant or the person that lodged the objection to provide further particulars within 60 days, in Form V set out in the First Schedule.

(2) A person who fails to provide further particulars as required under sub-regulation (1) shall be deemed to have abandoned that application or objection.

6. Determination of an objection

(1) The Registrar shall, within 60 days of receipt of the counter-statement or further particulars, determine an objection and communicate the decision of the Registrar to the applicant and the person who lodged the objection.

(2) Where the Registrar is of the opinion that an objection ought to be determined by an appropriate institution, the Registrar shall refer the objection to the appropriate institution and notify the parties accordingly.

(3) The appropriate institution referred to in sub-regulation (2) shall determine the objection and communicate its decision to the Registrar within 60 days of receipt of the objection.

(4) The Registrar shall communicate the final decision made under sub-regulation (3) to the applicant and the person who lodged the objection within 14 days of receipt of the decision.

7. Registration of traditional knowledge or expressions of folklore

The Registrar shall, within 30 days of the determination of an objection or within 30 days of the expiry of the period within which to lodge an objection—

(a) approve the application for registration of traditional knowledge or expressions of folklore, if the application meets the requirements of the Act; or

(b) reject the application, if the application does not meet the requirements of the Act and notify the applicant in writing stating the reasons for the rejection.

8. Certificate of registration

(1) The Registrar shall, where the Registrar approves an application for the registration of traditional knowledge or expressions of folklore, issue a certificate of registration in Form VI set out in the First Schedule.

(2) The Registrar shall cause to be entered in the Register the particulars of the registered traditional knowledge or expressions of folklore as provided in the Act.

9. Access to registered traditional knowledge or expressions of folklore

(1) A person who intends to access a registered traditional knowledge or expressions of folklore shall apply to the holder for prior informed consent on terms and conditions that the holder may determine.

(2) Where the holder cannot be found, a person may apply for prior informed consent to the Registrar in Form VII set out in the First Schedule.

(3) The Registrar may on receipt of an application under sub-regulation (2)—

(a) grant prior informed consent if the application meets the requirements under the Act; or

(b) reject the application and notify the applicants in writing stating the reasons for the rejection.

(4) The holder or Registrar may grant prior informed consent in Form VIII set out in the First Schedule.

(5) Where prior informed consent is obtained from the holder, a user shall, on payment of the fee set out in the Second Schedule, submit the prior informed consent to the Registrar for approval in Form IX set out in the First Schedule.

(6) The Registrar shall within 30 days of the receipt of an application under sub-regulation (4)—

(a) approve the prior informed consent if it meets the requirements of the Act; or

(b) reject the prior informed consent if it does not meet the requirements of the Act.

(7) The Registrar shall, in considering whether the holder has given prior informed consent, take the following into consideration—

(a) whether the holder had adequate knowledge of the value of the traditional knowledge or expressions folklore;

(b) whether the holder had sufficient time to consider the application and make necessary consultations; and

10. Application for approval of licensing agreement

(1) A holder who intends to authorise or licence the expressions of folklore may conclude a licensing agreement.

(2) The holder shall, on conclusion of the licensing agreement, apply to the Registrar for approval of the licensing agreement in Form IX set out in the First Schedule on payment of the fee set out in the Second Schedule.

(3) The Registrar shall within 30 days of receipt of the application for approval, approve or reject the licensing agreement.

(4) Where the Registrar rejects the application under sub-regulation (3), the Registrar shall inform the applicant in writing, stating the reasons for the rejection.

PART III
ACCESS TO GENETIC RESOURCES

11. Application for prior informed consent

(1) A person who intends to access genetic resources shall apply to the holder, for prior informed consent on terms and conditions that the holder may determine.

(2) Where the holder cannot be found, a person may apply for prior informed consent to the Registrar in Form VII set out in the First Schedule.

(3) The Registrar shall, within 30 days of receipt of an application under sub-regulation (2)—

(a) grant prior informed consent if the application meets the requirements under the Act; or

(b) reject the application and notify the applicant in writing stating the reasons for the rejection.

(4) The holder or the Registrar, may grant prior informed consent in Form VIII set out in the First Schedule.

(6) The Registrar shall in considering whether the holder has given prior informed consent take the following into consideration—

(a) whether the holder had adequate knowledge of the value of the resources being accessed;

(b) whether the holder had sufficient time to consider the application and make necessary consultations;

(d) where the genetic resource is communally owned, whether the views of the community were taken into account.

(7) On approval of the prior informed consent, the Registrar shall cause the particulars of the prior informed consent contract to be entered in the Register.

12. Access permit or exploration permit

(1) A person who intends to access genetic resources shall apply to the Registrar for an access permit in Form XIII set out in the First Schedule on the payment of the fee set out in the Second Schedule.

(2) A person who intends to explore genetic resources shall apply to the Registrar for an exploration permit in Form XIII set out in the First Schedule on the payment of the fee set out in the Second Schedule.

(3) Where the application for an access permit or exploration permit meets the requirements of the Act, the Registrar shall within 14 days of receipt of the application, submit a copy of the application to the appropriate institution for recommendation.

(4) The appropriate institution shall, within 60 days of receipt of the application for an access permit or exploration permit, communicate its recommendations, in writing, to the Registrar.

(5) The Registrar shall, on receipt of the recommendation from the appropriate institution, approve or reject the application for an access permit or exploration permit.

(6) Where the Registrar rejects the application under sub-regulation (5), the Registrar shall inform the applicant, in writing, stating the reasons for the rejection.

(7) Where the Registrar approves an application for an access permit or exploration permit, the Registrar shall issue an access permit or exploration permit in Form XIV and Form XV set out in the First Schedule, respectively.

(8) The Registrar shall cause to be entered in the Register the particulars of the access permit or exploration permit as provided in the Act.

(9) An access permit or exploration permit issued under this regulation shall be valid for a period of two years and may thereafter be renewed annually on the payment of the fee set out in the Second Schedule.

(10) An application for renewal of an access permit or exploration permit shall be in Form XVI set out in the First Schedule and shall be made at least three months before the expiry of the permit.

(11) The Registrar may, in consultation with the appropriate institution and the holder, renew an access permit or exploration permit in Form XVII set out in the First Schedule.

PART IV
GENERAL PROVISIONS

13. Access agreement

(1) A person who intends to access traditional knowledge or genetic resources shall sign an access agreement with the holder.

(2) The holder and user may adopt the model access agreement set out in Form X in the First Schedule.

(3) A user shall apply to the Registrar for approval of the access agreement in Form IX in the First Schedule on payment of the fee set out in the Second Schedule.

(4) The Registrar shall, within 14 days of receipt of the application under sub-regulation (3), cause the access agreement to be published in a newspaper of daily circulation in the Republic or other media.

14. Objection to access agreement

(1) A person may, within 30 days from the date of the publication of the access agreement, lodge an objection with the Registrar in Form III set out in the First Schedule.

(2) Regulations 4, 5 and 6 shall apply to an objection lodged under this regulation, with the necessary modifications.

15. Approval or rejection of access agreement

(1) The Registrar shall, within 30 days of the final determination of the objection to an access agreement—

(a) approve the access agreement if it meets the requirements of the Act; or

(b) reject the access agreement if it does not meet the requirements of the Act.

(2) On approval of the access agreement, the Registrar shall cause the particulars of the access agreement to be entered in the Register.

(3) Where the Registrar rejects the access agreement, the Registrar shall notify the holder and the user of the rejection in writing stating the reasons for the rejection.

16. Alteration, suspension or termination of access agreement

Where the Registrar alters, suspends or terminates an access agreement, the Registrar shall notify the holder and the user in writing.

17. Compulsory licence

(1) Where traditional knowledge or genetic resource that is protected in accordance with the Act, is not being sufficiently exploited by the holder or where the holder refuses to grant access, a person may, on payment of the fees set out in the Second Schedule, apply to the Minister for a compulsory licence in Form XI set out in the First Schedule.

(2) Subject to sub-regulation (1), the Minister may grant a compulsory licence in Form XII set out in the First Schedule.

18. Appointment of agent

(1) A person who intends to engage an agent for purposes of lodging any document under these Regulations with the Agency shall apply to the Registrar for appointment of an agent in Form XVIII set out in the First Schedule on the payment of the fee set out in the Second Schedule.

(2) Despite sub-regulation (1), a person that ordinarily does not reside in the Republic, shall lodge documents under sub-regulation (1) with the Agency through an agent.

19. Request for information from Register

A person may, on the payment of the fee set out in the Second Schedule, request the Registrar in Form XIX for a copy of a document recorded in the Register or any other particulars from the Register.

20. Notification of change of particulars

(1) A person whose details are registered in the Register or any other register maintained by the Agency shall notify the Registrar of any change in that person’s registered particulars.

(2) A notification under sub-regulation (1) shall be in Form XX set out in the First Schedule.

(3) The Registrar on receipt of the notification under sub-regulation (2), enter the changes in the Register.

21. Application for duplicate certificate

A holder may apply to the Agency for a duplicate certificate of registration in Form XXI set out in the First Schedule on the payment of the fee set out in the Second Schedule.

22. Application for amendment or correction of document

A person may apply to the Agency for the amendment or correction of a document lodged with the Registrar in Form XXII set out in the First Schedule on the payment of the fee set out in the Second Schedule.

23. Competent National Authority and National Focal Point

For purposes of the Nagoya Protocol—

(a) the Agency shall be the Competent National Authority responsible for—

(i) grant of access permit under the Act;

(ii) issuance of written evidence that access requirements have been met; and

(iii) giving advice on applicable procedures and requirements for obtaining prior informed consent; and

(b) the Ministry responsible for natural resources shall be the National Focal Point for purposes of providing information on—

(i) procedures for obtaining prior informed consent and establishing mutually agreed terms for applicants seeking to access genetic resources or traditional knowledge associated with genetic resources; and

(ii) appropriate institutions and relevant indigenous and local communities.

24. Fees

The fees set out in the Second Schedule are payable for the matters specified therein.

FIRST SCHEDULE

[Regulations 3, 4, 5, 7, 8, 9, 10, 13, 14, 15, 16, 19, 20 and 21]

FORM I

[Regulation 3(1)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE
TRADITIONAL KNOWLEDGE EXPRESSIONS OF FOLKLORE (Tick [ ] where applicable)
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Time
TO THE REGISTRAR:
Details of applicant
(a) Full names
(b) Nationality
(c) Residential address
(d) Identity number
(e) Mobile number
(f) E-mail address
Details of holder
(a) Full names
(b) Nationality
(c) Identity number
(d) E-mail address
(e) Mobile number
(f) Physical address
1. Description of the traditional knowledge expressions of folklore and its associated economic, social scientific, technical, environmental or any other benefit that is likely to accrue to the traditional community or a holder.
………………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………………….
2. Use of the traditional knowledge expressions of folklore (in the traditional context)
………………………………………………………………………………………………………………………….
………………………………………………………………………………………………………………………….
3. I/WeDelete what is not applicable* ………………………..…………………………………………………………………. being the holder/representative do authorise/do not authoriseDelete what is not applicable* the Agency to grant prior informed consent in respect of the above stated traditional knowledge expressions of folklore
3. Date ……………………
……………………………………………… Signature of holder/representative
FOR OFFICIAL USE
Application received by: ………………..
Date received: ……………………………

FORM II

[Regulation 3(2)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

NOTICE OF APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE

Traditional knowledge Expressions of folklore

NOTICE is given that an application for registration of the traditional knowledge/expressions of folkloreDelete what is not applicable* has been filed with the Registrar.

DETAILS OF APPLICATION

1. Type and economic value of traditional knowledge/expressions of folkloreDelete what is not applicable* …………………………

………………………………………………………………………………………………………………………..

2. Registration No. …………………………………………………………………………………………………..

3. Name of applicant ………………………………………………………………………………………………..

4. Name of holder ……………………………………………………………………………………………………

5. Location …………………………………………………………………………………………………………….

A person who has an objection to this registration shall lodge the objection, in writing, with the Registrar within sixty days of the date of publication of this notice.

Dated this …………. day of …………………. 20……

……………………………..
Registrar

FORM III

[Regulations 4(1) and 14(1)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

NOTICE OF OBJECTION
	TO THE REGISTRAR:
	I/WeDelete what is not applicable…………………………………………………………..…………..……… give notice of my/ourDelete what is not applicable intention to object to:
	(a) the registration of traditional knowledge/expressions of folkloreDelete what is not applicable*
	(b) licensing/assignmentDelete what is not applicable* of traditional knowledge
	(c) licensing/assignmentDelete what is not applicable* of expressions of folklore
	(d) access agreement
Here insert the reference No. of registration/ licensing/ assignment/ access agreement	which appeared in the ………………………………………………………….…………… of the ……….… day of ……………………… 20……….., on page number …………………. under the ……….. number ……………
The grounds of objection are as follows:
(a) …………………………………………………………………………………….
(b) ………………………………………………………………………………….…
(c) …………………………………………………………………………………….
	Dated this ………. day of …………..…….. 20……..

	………………………………………………… Signature of the person objecting
FOR OFFICIAL USE ONLY
Received by: …………………………..
Date received: ………………………….

FORM IV

[Regulation 4(3)]

(To be completed in duplicate)

Counter-Statement No.: ……………..

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

COUNTER-STATEMENT TO AN OBJECTION
TO: THE REGISTRAR
Details of application or agreement number
(1) Here insert application or agreement number	IN THE MATTER of application for registration of traditional knowledge/expressions of folklore/access agreement/licensing agreementDelete what is not applicable*(1) number ……………………………………………………………………………………
Grounds in support of application
(2) Here insert grounds relied on to support application (in case of additional information attach extra sheets)	I/WeDelete what is not applicable* ………………………………………………………………………………………. the applicant(s) of the above traditional knowledge/expressions of folklore/access agreement/licensing agreementDelete what is not applicable* (2) number ………………………………………….. ………………………………………………………………………………………., give notice that the following are the grounds on which I/weDelete what is not applicable* rely for my/ourDelete what is not applicable* application:
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
Allegations admitted
(3) Here insert allegations admitted if any	I/WeDelete what is not applicable* admit the following allegations in the notice of objection (3):
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
(4) Here insert signature of holder/ representativeDelete what is not applicable*	Dated this ………… day of ……….……… 20……
(4) …………………………………….. Holder/representativeDelete what is not applicable*

FORM V

[Regulation 5(1)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

REQUEST FOR FURTHER PARTICULARS
(1) Here insert full names and address of holder/ representative/ objector	1. To: Full name (1) …………………………………………………………………… of
………………………………………………………………………………………………..
………………………………………………………………………………………………..
(2) Here insert the application number or number for the agreement	2. IN THE MATTER of application for registration of traditional knowledge/expressions of folklore/access agreementDelete what is not applicable* (2) number ………….. ……………………………………………………………………………………………….. ……………………………………………………………………………………………….. ………………………………………………………………………………………………..
INFORMATION REQUESTED FOR
(3) Here provide the requested information	3. You are requested to provide the following information: (1) ………………………………………………………………………………………………. ………………………………………………………………………………………………..
(2) ………………………………………………………………………………………………. ………………………………………………………………………………………………..
(3) ………………………………………………………………………………………………. ………………………………………………………………………………………………..
	4. The information requested in the paragraph (3) above should be provided within thirty days of the receipt of this request. In the event that the requested information is not provided within the stated period, you will deemed to have abandoned the objection to the application/agreementDelete what is not applicable*.
	Received by: ……………………………………………………….
Name and signature
Date received: …………………………………………………….
FOR OFFICIAL USE ONLY
Received by: ……………………………………………………………………………………
Officer’s name and signature
Date received: …………………………………………………………………………………..

FORM VI

[Regulation 8(2)]

(To be completed in duplicate)

Certificate No.: ……………………

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

CERTIFICATE OF REGISTRATION FOR TRADITIONAL KNOWLEDGE/EXPRESSIONS OF FOLKLORE

Name of traditional community/group/individualDelete what is not applicable*: ………………………………….………..…………

Address: ………………………………………………………………………………………………………….……

Description of the traditional knowledge/expressions of folkloreDelete what is not applicable*: ………………………………………… …………………………………………………………………………………………………………………………….

This is to certify that the traditional community/group/personDelete what is not applicable* named on this certificate has been registered as the holder of the traditional knowledge/expressions of folkloreDelete what is not applicable* described above.

Given on this ……….. day of …………………… 20……

…………………………….
Registrar

FORM VII

[Regulations 9(2) and 11(2)]

(To be completed in duplicate)

Application No.: …………………

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPLICATION FOR PRIOR INFORMED CONSENT
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Time
TO: AGENCY/HOLDERDelete what is not applicable*
DETAILS OF APPLICANT
(a) Full names
(b) Nationality
(c) Identity number
(d) Telephone number
(e) Mobile number
(f) Physical address
(g) E-mail address
I/WeDelete what is not applicable* apply for prior informed consent in respect of the following traditional knowledge/genetic resources/expression of folkloreDelete what is not applicable* ………………………………………………………………………….
1. Traditional knowledge/genetic resources/expression of folkloreDelete what is not applicable* registration number (where applicable): …………………………………………………………………………………………………
2. The reasons for prior informed consent: ……………………………………………………………
3. I/WeDelete what is not applicable* declare that I am/we are willing to enter into an agreement on mutually agreed terms.
4. I/WeDelete what is not applicable* declare further that to the best of my/our knowledge, the information given in this application is correct and true and that the prior informed consent will only be used for the reasons stated in this application.
Dated this ………. day of …………..……… 20……

…………………………………. Signature of applicant
FOR OFFICIAL USE ONLY
Application received by: ……………………
Date received: ………………………………

FORM VIII

[Regulations 9(4) and 11(4)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

PRIOR INFORMED CONSENT

To applicant: ……………………………………………………………………………………………………………..

Address of applicant: …………………………………………………………………………………………………..

I/WeDelete what is not applicable* ……………………………………………………………………………………………………………. being the holder/agencyDelete what is not applicable* acting on behalf of the following traditional knowledge/genetic resources/expression of folkloreDelete what is not applicable*………………………………………. located at ………………………………………………….. consent that the above named applicant may access the above stated traditional knowledge/expression of folkloreDelete what is not applicable* apply to the agency for an access permit in respect of the above stated genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable*.

This consent is valid from ……………… 20…… to ……………20..… and is subject to the following conditions:

(i) …………………………………………………………………………………………………………………..

(ii) …………………………………………………………………………………………………………………..

(iii) …………………………………………………………………………………………………………………..

(iv) …………………………………………………………………………………………………………………..

(v) …………………………………………………………………………………………………………………..

The applicant has obtained the following agreements:

(i) …………………………………………………………………………………………………………………..

(ii) …………………………………………………………………………………………………………………..

(iii) …………………………………………………………………………………………………………………..

Dated this …..…… day of …………………. 20……

………………………………….
Registrar/Holder

Endorsements:

……………………………………………………………………….……………

Dated this ……….. day of …………………. 20…….

FORM IX

[Regulations 9(5), 10(2), 11(5) and 13(3)]

(To be completed in duplicate)

Application No.: …………………..

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPLICATION FOR APPROVAL OF PRIOR INFORMED CONSENT
ACCESS AGREEMENT LICENSING AGREEMENT
(Tick [ ] where applicable)
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Time
TO THE REGISTRAR:
Details of user
(1) Here insert full names of user	Full names ……………………………………………………………….…………..
Identity number ……………………………………………………………………………….
Nationality ……………………………………………………………………………………..
Telephone number…………………………………….…………………………….
Mobile number ……………………………..………….……………….……………
Residential address ………………………………………………………………………..
E-mail address ……………………….…………..…………………………………..
(2) Here insert full names of user	IN THE MATTER of an application for the approval of the attached prior informed consent contract/access agreement/licensing agreementDelete what is not applicable* between (2) ……………………………………………….………………………………………
(3) Here insert full names of holder	………………………………… and (3) ………………..…………………………..
…………………………………….…………………………………………………
Instructions:
(a) applicant for approval of access agreement and prior informed consent to attach signed copy of prior informed consent;
(b) applicant for approval of licensing agreement to attach signed copy of licensing agreement.
FOR OFFICIAL USE ONLY
Received by: ……………………………………………… Officer’s name and signature
Date received: …………………………………………

FORM X

[Regulation 13(2)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

MODEL ACCESS AGREEMENT

THIS AGREEMENT made the ………. day of ………………….. Two thousand ………………………

BETWEEN …………………………………….….. of ……………………………..….. (hereinafter referred to as “the holder”) of the one part and ………………..……………… of ………………………….……….Indicate registered office if it is a company* (hereinafter referred to as “the User”) of the other part.

WHEREAS the holder of the traditional knowledge/genetic resourceDelete what is not applicable* described in the First Schedule is a traditional community/group/individualDelete what is not applicable*.

AND WHEREAS the holder confirms that the holder has been informed of the research/exploitationDelete what is not applicable* by the User and consents to provide access to the traditional knowledge/genetic resourcesDelete what is not applicable* in situ or ex situDelete what is not applicable* necessary to carry out the research/exploitationDelete what is not applicable* in accordance with the project described in the Second Schedule.

AND WHEREAS this Agreement is intended to specify the terms for accessing traditional knowledge/genetic resources,Delete what is not applicable* its utilisation in accordance with the prior informed consent, and for sharing the benefits resulting from the utilisation of traditional knowledge/genetic resources.Delete what is not applicable*

NOW THIS AGREEMENT WITNESSETH as follows:

1.0 INTERPRETATION

1.1 The words defined in the Act shall have the same meaning in this Agreement, unless otherwise defined in this clause.

1.2 In this Agreement, unless the context otherwise requires—

“associated traditional knowledge” means any experimental or observational data, information and other findings on the composition, life conditions and functions of the accessed genetic resources;

“commercialisation” means the use of the traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable* for the generation of any kind of actual or potential economic profit;

“product” means the result produced, obtained, extracted or derived from the traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable* through research or research and development activities, including data and information generated through analysis of the traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable*;

“utilisation for proprietary purposes” means research and development that aims at protecting the traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable*, including products and processes developed, by intellectual property rights, keeping the associated traditional knowledge secret, making the associated traditional knowledge accessible at minimal cost for dissemination or bringing the products and processes developed from the accessed genetic resources on the market;

“utilisation for the public domain” means research and development that aims at making the genetic resources or associated traditional knowledge, including products and processes developed, available to the public at a minimal cost for dissemination, and without being protected by patent rights or further restricted by other intellectual property rights;

“utilisation of traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable*“ means research and development on the genetic or biochemical composition of the accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable*, including through the application of biotechnology to make or modify products or processes for specific use.

2.0 ACCESS TO GENETIC RESOURCES

2.1 The User shall be entitled to collect samples as follows:Indicate the type of samples, quantity of samples and location of collection*

2.2. The User shall withinPeriod to be specified by the Parties* Delete what is not applicable*after collection of the samples notify the holder/representative of the holderDelete what is not applicable* the types of samples the User intends to utilise. The holder/representative of the holderDelete what is not applicable* may, within ………… (3) after receiving the notice, raise an objection in which case the parties will have to agree on the types of samples allowed to be utilised.

2.3 The User shall bear all the costs incurred in accessing and preserving the traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable*.

3.0 UTILISATION OF THE TRADITIONAL KNOWLEDGE/GENETIC RESOURCESDelete what is not applicable*

3.1 The User shall be entitled to utilise the accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable* in accordance with clause 2.0.

3.2 The accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable* shall be for commercialisation/utilisation for proprietary purposes/utilisation for public domainDelete what is not applicable*.

SpecificationsSpecify the details of the intended utilisation of the accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resources*

3.3 Where the accessed traditional knowledge/genetic resourcesDelete what is not applicable* is for commercialisation/utilisation for public domainDelete what is not applicable* and after the conclusion of this Agreement, the User intends to utilise the accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resourcesDelete what is not applicable* for proprietary purposes, the User shall seek the consent of the holder.

3.4 Where the User intends to change the utilisation of the accessed traditional knowledge/genetic resources/traditional knowledge associated with genetic resources from non-commercial to commercial the User shall obtain a new prior informed consent issued by the holder or the Agency. In this case, the terms of the commercialisation shall be subject to a separate benefit sharing agreement between the Parties.

4.0 TRANSFER OF GENETIC RESOURCES TO THIRD PARTIES

4.1 A User may transfer the genetic resources and their associated traditional knowledge to third parties after having obtained the written consent of the holder and in accordance with mutually agreed terms between the holder and the third party unless where a transfer is for purposes of scientific identification by a taxonomic specialist.

4.2 Despite clause 4.1, the User shall be entitled to deposit the genetic resources in collections that are accessible without restrictions for research purposes such as herbaria, museums and culture collections.

4.3 Where the User transfers the collection of living genetic resources, for educational purposes, to a site outside their natural habitat or ecosystem, the User shall take appropriate precautions to prevent an unauthorised person from being in possession of the genetic resources.

4.4 The User shall maintain retrievable records of any transfer of the genetic resources to third parties under the conditions corresponding to this Agreement and allow access to such records to the holder or the authority designated by the Agency …………………………………………. (insert name and address of authority if applicable).

5.0 SCIENTIFIC COLLABORATION AND CAPACITY-BUILDING

The User agrees to collaborate with scientists from within Zambia in the utilisation activities based on this Agreement. The collaboration shall be as follows:Here specify the details of the collaboration*

6.0 BENEFIT-SHARING IN CASE OF UTILISATION FOR PROPRIETARY PURPOSES

6.1 The benefits arising from the access and use of the genetic resources shall be shared fairly and equitably by the User, in accordance with the principles established in the Act. Basic benefits to be shared include—

(a) an offer to the holder to include local researchers in the research activities, where necessary;

(b) in case of publications or oral presentation of the research results, acknowledgement is to be given to the source of the genetic resource/traditional knowledgeDelete what is not applicable*;

(c) if traditional knowledge associated to the genetic resources is used in the research, results published or presented orally will include full acknowledgement of the source of the genetic resources and the traditional knowledge, if so required by the holder;

(d) the holder will receive a copy of all publications;

(e) research results will be communicated to involved stakeholders in an adequate manner and according to reasonable requirements of the holder;

(f) if applicable the User should share the duplicate specimens with the repository in Zambia in accordance with good scientific practice.

In addition the parties agree as follows:

6.2 The User agrees to pay an up-front compensation of …………… (amount to be specified) to the holder, if the User utilises the accessed genetic resources for proprietary purposes. The payment is due to the holder within …….. months (term to be specified) after consent on the kinds of genetic resources to be utilised has been reached under clause 2.0. The payment shall be transferred to the following account of the holder/representative of the holderDelete what is not applicable*:This clause is to be crossed out if not applicable* …………………………………………………………………………………………………

6.3 Where the User utilises the accessed genetic resources or uses the associated knowledge for proprietary purposes according to clause 3.3 and 3.4, it must fairly and equitably share with the holder any monetary benefit obtained.

6.4 The share shall be determined by further negotiations between the Parties to this agreement.

6.5 (Alternative to 6.4) The share shall be …………. per cent of the revenue from sales of the product or process based on the accessed genetic resources. It shall be paid on the basis of a financial report to be sent to the holder or an authority designated by the Agency at the end of any year of any revenue generation to the account designated by the same.

…………………………………………………………………………………………………………………………..

(Insert authority and account details if applicable)

6.6 If the User utilises the accessed genetic resources or utilises the associated traditional knowledge for proprietary purposes without being entitled according to clause 3.3 or 3.4 and therefore in breach of the conditions of this agreement it must share with the holder any monetary benefit obtained from such utilisation or use. The share shall be ……. per cent of the revenue from sales of the product or process based on the accessed genetic resources. It shall be paid on the basis of a financial report to be sent to the holder or an authority designated by the Agency in due time upon request by the same.This article or single paragraphs of it are to be crossed out if not applicable*

…………………………………………………………………………………………………………………………..

(Insert authority and account details if applicable)

7.0 RESPECT FOR OTHER LAWS

The User shall ensure that the collection, storage, transfer, utilisation and exportation of the genetic resources complies with all applicable laws of the republic of Zambia on the protection of human health and the environment, on taxes, on customs and any other concern.

8.0 DURATION OF THE AGREEMENT

The Agreement shall be for a duration of …………. commencing from ……….. to ………….

9.0 APPLICABLE LAW

The applicable law on any matters relating to the interpretation and the application of the present Agreement shall be …………………………………..

10.0 DISPUTE SETTLEMENT

10.1 No Party shall, in the event of a dispute arising from this Agreement, commence court proceedings (except proceedings for urgent interlocutory relief) before searching for an amicable solution according to paragraphs 9.2 and 9.3 of this clause.

10.2 A Party to this Agreement claiming that a dispute has arisen under or in relation to this Agreement must serve the other Party with a written notice specifying the nature of the dispute on receipt of which the dispute resolution shall forthwith begin.

10.3 Any dispute arising from this Agreement shall be resolved expeditiously foremost by negotiation in good faith failure to which the Parties shall engage informal dispute resolution techniques, such as mediation and arbitration or similar techniques agreed to by them.

11. TERMINATION OF THE AGREEMENT

11.1 The agreement may be terminated at any time by mutual agreement in writing.

11.2 The agreement may be terminated by default if the User fails to satisfy any of the obligations under this Agreement.

11.3 In the case of default by the User, the holder may immediately terminate this Agreement by giving written notice to the User of the termination, provided that—

(a) the holder has given prior notice to the User of the alleged default; and

(b) the user fails to respond to the holder within the period specified by the notice (being not less than 20 business days and not more than 60 business days) to rectify or explain to the satisfaction of the holder the reasons for the default.

12.0 RESPONSIBLE PERSON

The holder designates the following institution [insert the relevant institution] as the responsible contact point for the entire duration of the present Agreement. Contact details of the technical contact point are as follows:

………………………………………………………………………………………………………………..

13.0 INTELLECTUAL PROPERTY RIGHTS

13.1. The User shall not claim any intellectual property rights over the traditional knowledge/genetic resourceDelete what is not applicable* in the form received. If the User wants to obtain intellectual property rights on research results such act shall be treated as change in utilisation and thus shall be regulated under clause 3.5 of this Agreement. In particular the ownership of the IPR and the distribution of the value derived from the IPR are to be negotiated.

14.0 DATA SHARING

14.1 The User agrees that the Provider has the right to access the following data resulting from the research/utilisation …………………………………………………………. [insert type of data]

14.2 The User shall facilitate access to the above defined data for the holder.

AS WITNESS the hands of the parties hereto or their duly authorised agents the day and year first before written.

SIGNED by holder )

in the presence of: )

WITNESS

Name:

Address:

Occupation:

SIGNED by User )

in the presence of: )

WITNESS

Name:

Address:

Occupation: (Footnotes)

FORM XI

[Regulation 17(1)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPLICATION FOR A COMPULSORY LICENCE
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Time
TO: THE MINISTER
Details of Applicant
Full names ………………………………………………………………………………………………………………
Identity number …………………………………………………………………………………………………………
Nationality ……………………………………………………………………………………………………………….
Residential address ……………………………………………………………………………………………………
Telephone number ……………………………………………………………………………………………………..
Mobile number ………………………………………………………………………………………………………….
E-mail address ………………………………………………………………………………………………………….
Details pertaining to the traditional knowledge/genetic resourcesDelete what is not applicable* to be accessed
(1) Here insert full name of holder	1. Full name of holder ………………………………………………………………………….
……………………………………………………………………………………………………….
(2) Here give a brief description of the traditional knowledge/genetic resources to be accessed	2. Type of traditional knowledge/genetic resourcesDelete what is not applicable* to be accessed (2) ……………
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
(3) Here give the salient features of the traditional knowledge/ genetic resourceDelete what is not applicable*	3. Description of the intended use of the traditional knowledge/genetic resourceDelete what is not applicable* (3)
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
Grounds for application
	1. This application is based on the following grounds:
(a) traditional knowledge/genetic resourceDelete what is not applicable* is not being sufficiently exploited by the holder
(b) the holder has refused to grant access subject to reasonable commercial terms and conditions
2. The application for compulsory license is made in the interest of public security/public healthDelete what is not applicable* on the basis of the following reasons:
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
……………………………………………………………………………………………………….
NOTE: Where necessary attach supporting documents
Dated this ………. day of ………………….. 20………
	………………………………… Signature of Applicant
FOR OFFICIAL USE ONLY
Received by: ……………………………………………… Officer’s name and signature
Date received: ……………………………………………

FORM XII

[Regulation 17(2)]

(To be completed in duplicate)

Compulsory Licence No.: …………..

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

COMPULSORY LICENCE FOR TRADITIONAL KNOWLEDGE GENETIC RESOURCESDelete what is not applicable* (Tick [] where applicable)
Issued by: The Minister responsible for commerce
(1) Here insert the name of the applicant	To (1): …………………………………………………………………………………………..
of (2) …………………………………………………………………………………………….
(2) Here insert the full physical address of the applicant	……………………………………………………………………………………………………
WHEREAS the applicant in application No. ………. applied for access to the following traditional knowledge/genetic resourcesDelete what is not applicable*: (3)
(3) Here describe the traditional knowledge/ genetic resources applied for	……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
	……………………………………………………………………………………………………
	……………………………………………………………………………………………………
(4) Here insert name of holder	held by (4) ……………………………………………………………………………………..

	WHEREAS the traditional knowledge/genetic resourceDelete what is not applicable* described in paragraph (3) is not being sufficiently exploited by the holder or where the holder refuses to grant access subject to reasonable commercial terms and conditions.
WHEREAS the applicant desires the right to access the said traditional knowledge/genetic resourcesDelete what is not applicable* as follows:
(5) Here insert the intended use of the genetic resource/ traditional knowledgeDelete what is not applicable*	(5) ………………………………………………………………………………………………..
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
	WHEREAS in the interest of public security/public healthDelete what is not applicable*, I grant this compulsory licence on the following conditions:
	1. The applicant has the right to make use of the accessed traditional knowledge/genetic resourceDelete what is not applicable* as specified in the compulsory license.
	2. In consideration of the compulsory licence, the applicant shall pay the holder a sum of (6) ……………………………………………………………………………….
(6) Here insert the amount to be paid by the applicant as set by the Minister	3. This compulsory licence is binding on—
(a) the holder and applicant; or
(b) in the case of traditional knowledge held by an individual, the heirs, legal representatives, successors, and an assignee of the individual holder.
	4. In the case of genetic resources, the quantity to be accessed by the applicant is (7) …………………………………………………………………………..
	5. This compulsory licence is valid for a period of …………………………………..
(7) Here indicate the quantities to be accessed by the applicant
Dated this ……….. day of ……………, 20………

………………………………. Minister

FORM XIII

[Regulation 12(1) and (2)]

(To be completed in duplicate)

Application No. …………..

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPLICATION FOR ACCESS PERMIT OR EXPLORATION PERMIT
ACCESS PERMIT EXPLORATION PERMIT
(Tick [] where applicable)
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Time
TO THE REGISTRAR:
PART A ACCESS PERMIT
Details of applicant
(a) Full names
(b) Nationality
(c) Residential address
(d) Identity number
(e) Mobile number
(f) E-mail address
Details of traditional knowledge/genetic resourcesDelete what is not applicable*
(1) Here insert a brief description of the traditional knowledge/ genetic resourcesDelete what is not applicable* to be accessed	This application is for an access permit to access the following traditional knowledge/genetic resourcesDelete what is not applicable*: (1) ………………………………………………..
…………………………………………………………………………………………………….
…………………………………………………………………………………………………….
…………………………………………………………………………………………………….
…………………………………………………………………………………………………….
Accompanying documents
Documents accompanying the application—
(a) a written prior informed consent
(b) an access agreement
(c) an Environmental Impact Assessment Report (where applicable)
(d) a detailed project proposal
Officer to tick documents received
PART B EXPLORATION PERMIT
Details pertaining to the genetic resources
(1) Here insert a brief description of the genetic resources to be explored	The applicant applies for an exploration permit to explore the following genetic resources: (1) …………………………………………………………………………….
……………….………………………………………………………………………………
……………….………………………………………………………………………………
(2) Here insert a clear description of the physical location of the genetic resources	……………….………………………………………………………………………………
The location of the genetic resource listed in paragraph (1) is (2) ………………..
……………….………………………………………………………………………………
……………….………………………………………………………………………………
(3) Here indicate the full duration of the exploration and attach the time schedule for the exploration	The estimated duration for the exploration is (3) ………………………………….. …………………………………………………………………………………………………….
……………….………………………………………………………………………………
Purpose for the exploration permit
	The exploration permit is required for the following purposes:
	(a) ……………………..………………………………………………………
	………………………………………………………………………………
	(b) ………..……………………………………..…………………………….
	(c) ………………………………………..……………………………………
	………………..……………….……………………………………………
	(d) ………………………………………..……………………………………
Attachments
Please attach the Access Agreement
Dated this ……… day of ……….………… 20……

……………………………………… Signature of applicant
DECLARATION
I/WeDelete what is not applicable* the applicant declare that the information provided herein and the accompanying documents are true and correct to the best of my/ourDelete what is not applicable* knowledge.
I/WeDelete what is not applicable* declare further that to the best of my/ourDelete what is not applicable* knowledge, I/weDelete what is not applicable* have complied with the relevant laws and regulations as per the documents.
Dated this ……….. day of ……………..……… 20……
…………………………………… Signature of applicant
FOR OFFICIAL USE ONLY
Received by: ……………………………………………… Officer’s name and signature
Date received: ……………………………………………

FORM XIV

[Regulation 12(7)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

ACCESS PERMIT
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Place of issue
Details of applicant
Full names
Identity number
Nationality
Residential address
Telephone number
Mobile number
E-mail address
1. Subject to any other written law or agreement concluded between the holder and applicant, the above named applicant is authorised to access the following genetic resources located at ………………………………………………………………….…………………………………..
(a) ……………………………………………………………………………………………………
(b) ……………………………………………….…………………………………………………..
(c) ……………………………………………………………………………………………………
2. This permit is valid from ……..……….. 20…… to …………….. 20…..

………………………………. Registrar

FORM XV

[Regulation 12(7)]

(To be completed in duplicate)

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

EXPLORATION PERMIT
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Place of issue
Details of user
Full names
Identity number
Nationality
Residential address
Telephone number
Mobile number
E-mail address
Details of genetic resources
2. Subject to any other written law and any other agreement concluded between the holder and applicant, the above named user is authorised to explore the following genetic resources located at ………………………………………………:
(a) ……………………………………………………………………………………………………
(b) ……………………………………………….…………………………………………………..
(c) ……………………………………………………………………………………………………
Purpose of exploration permit
3. The exploration permit is issued for the following purposes:
(a) ………………………………………………………………………………………………………
………………………………………………………………………………………………………
(b) ………………………………………………………………………………………………………
………………………………………………………………………………………………………
(c) ………………………………………………………………………………………………………
…………………………………………………………………………………………….………..
(d) ………………………………………………………………………………………………………
…………………………………………………………………………………………….………..

This permit is valid from …………….. 20….. to ……………… 20….

(a) deposit a copy of the exploration permit with the relevant appropriate institution in the district where the exploration is to be undertaken;

(b) strictly observe the terms and conditions specified in the exploration permit;

(c) present, on completion of the exploration, to the Agency, or an appropriate institution designated by the Agency, a detailed report and plan of the exploration undertaken;

(d) show, on request by an appropriate institution or person having an interest in the property in which the exploration is being undertaken, the exploration permit;

(e) respect local customs, traditions, values and property rights in the locality where the exploration is being undertaken; and

(f) observe and comply with the other relevant laws.

1. This permit may be withdrawn by the Agency should the holder breach any of the laws of the Republic of Zambia or any of the conditions contained in the Access Agreements.

2. This permit is not transferrable.

Dated this ………… day of …………..…… 20………

………..…………….…
Registrar

FORM XVI

[Regulation 12(10)]

Application No.: ……………

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPLICATION FOR RENEWAL OF ACCESS PERMIT OR EXPLORATION PERMIT
ACCESS PERMIT EXPLORATION PERMIT
(Tick [ ] where applicable)
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Time
TO THE REGISTRAR:
Details of Permit Holder
Full names ……………………………………………………………….…………………………….
Identity number …………………………………………………………………………………………………
Nationality ……………………………………………………………………………………………………….
Residential address ……………………………………………………………………………………
Telephone number ………………………………………………………….…………………………
Mobile number ………………………………………………………………………………………………….
E-mail address ……………………….…………..……………………………………………………..

1. Here insert the date of expiry of the access/ explorationDelete what is not applicable* permit	The access/explorationDelete what is not applicable* permit holder applies for the renewal of the access/explorationDelete what is not applicable* permit which is due to expire on (1) …………. day of …………………. 20……
Accompanying documents
2. Here describe full details and conditions of access/ explorationDelete what is not applicable* permit and any other accompanying documents	1. The following documents are attached to this application:
(a) current permit
(b) written prior informed consentDelete what is not applicable*
(c) an access agreementDelete what is not applicable*
(d) an Environmental Impact Assessment ReportDelete what is not applicable* (where applicable)
(e) a detailed project proposal where there is a new project or the project has changedDelete what is not applicable*

Dated this ………… day of ……….………… 20……

…………………………………. Signature of applicant
DECLARATION
I, the applicant declare that the information provided herein and the accompanying documents are true and correct to the best of my knowledge.
Officer to tick box where relevant document attached.
FOR OFFICIAL USE ONLY
Received by: …………………………………………. Officer’s name and signature
Date received: ………………………………………..

FORM XVII

[Regulation 12(11)]

Application No.: ………….

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

RENEWAL OF ACCESS PERMIT OR EXPLORATION PERMIT
ACCESS PERMIT EXPLORATION PERMIT
(Tick [ ] where applicable)
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Time
Details of permit holder
Full names ……………………………………………………………….……………………………
Identity number ………………………………………………………………………………………………..
Nationality ………………………………………………………………………………………………………
Residential address ………………………………………………………………………………………….
Telephone number ………………………………………………………………………………..….
Mobile number ………………………………………………………….………………………..……
E-mail address ……………………….…………..……………………………………………..……..

This renewal is effective from ………………. to …………………

Dated this ….……. day of ………………… 20……

FORM XVIII

[Regulation 18(1)]

Application No.: ………..

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPOINTMENT OF AGENT
TO THE REGISTRAR:
Details of applicant
(1) Here also indicate if user or holder	Full names (1) ………………………………………………………….……………
Identity number ………………………………………………………………………………
Nationality …………………………………………………………………………………….
Residential address ………………………………………………..……………….
Telephone number …………………………………………….……….……………
Mobile number ……..……………………………………………………………………….
E-mail address ……………………….…………..…………..……………………..
Details of agent
	Full names ………………………………………………………………………………………
Identity number …………………………………………………………………………………
Nationality ……………………………………………………………………………………….
Residential address ……………………………………………………………………………
Telephone number ……………………………………………………………………………..
Mobile number ………………………………………………………………………………….
E-mail address ………………………………………………………………………………….
(2) Here indicate the relevant subject matter	I/WeDelete what is not applicable……………………………………….………………………………………………………………………………………………………………………..… authorise the above named person/firmDelete what is not applicable to act as my/ourDelete what is not applicable* agent in respect of (2) …………………………………………………………………………………….. ……………………………………………………………………………………… and request that all notices, requisitions and communications relating thereto may be sent to the agent at the above address.
I/WeDelete what is not applicable* further revoke all previous authorisation/appointment, if any, in respect of the subject matter.
Dated this …..……. day of ……….……….…, 20……

……………………………………… Signature of applicant
FOR OFFICIAL USE ONLY
Received by: ……………………………………………… Officer’s name and signature
Date received: ……………………………………………

FORM XIX

[Regulation 19]

Notice No.: …………….

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

REQUEST FOR INFORMATION
TO THE REGISTRAR:
Details of applicant
Full names (1) ………………………………………………………….…………………………….
Identity number ……………………………………………………………………………………………….
Nationality ……………………………………………………………………………………………………..
Residential address ……………………………………………………………………..………….
Telephone number ……………………………………………..……………………..……………
Mobile number ……..……………………………………………………………………………………….
E-mail address ……………………….…………..……………………………..…………………..
(1) Here insert name of holder/representativeDelete what is not applicable*	I/WeDelete what is not applicable* (1) ………………………………………..………………….………………..
…………………………………………………………………………………………
(2) Here specify whether holder/representativeDelete what is not applicable*	in my/ourDelete what is not applicable* capacity as (2) ……………………….. give notice of the changes in the particulars entered in the Register (3) ……………………………………………… ……………………………..……………………………………………………………… ………………………………………………………………………… as follows:
(3) Here specify name of register	……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
Dated this ………….. day of ……….………, 20……

……………………………………………………… Signature of Holder/RepresentativeDelete what is not applicable*
FOR OFFICIAL USE ONLY
Received by: ……………………………………………… Officer’s name and signature
Date received: ……………………………………………

FORM XX

[Regulation 20(2)]

Notice No.: ………….

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

NOTICE OF CHANGE OF PARTICULARS
TO THE REGISTRAR:
Details of applicant
(1) Here insert name of holder/representativeDelete what is not applicable*	I/WeDelete what is not applicable*(1) …………………………………….…………………………………………
…………………………………………………………………………………………
(2) Here specify whether holder/representativeDelete what is not applicable*	in my/ourDelete what is not applicable* capacity as (2) …………………………………………………………… give notice of the change(s) in the particulars entered in the Register (3) …………………..………………………………………………………………………………………………………… as follows:
(3) Here specify name of register	……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
……………………………………………………………………………………………………
Dated this ……….. day of ……….……….…………, 20…..

………………………………………………….. Signature of Holder/RepresentativeDelete what is not applicable*
FOR OFFICIAL USE ONLY
Received by: ……………………………………………… Officer’s name and signature
Date received: ……………………………………………

FORM XXI

[Regulation 21]

Application No.: …………

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPLICATION FOR DUPLICATE CERTIFICATE FOR TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLOREDelete what is not applicable*
TRADITIONAL KNOWLEDGE EXPRESSIONS OF FOLKLORE
(Tick [ ] where applicable)
Please write in BLOCK LETTERS	Shaded fields for official use only	Application No.
Date/Time
TO: THE REGISTRAR:
Details of applicant

	Full names ……………………………………………………………………………
Identity number ……………………………………………………………………………….
Nationality ……………………………………………………………………………………..
Residential address …………………………………………………………………………
Telephone number …………………………………………..………………………
Mobile number ………………………………………………………………………
E-mail address …………………………………………………………….…………
(1) Here insert name of holder/ representativeDelete what is not applicable*	I/WeDelete what is not applicable* (1) …………………………………………………………….……………….
…………………………………………………………………………………….……
(2) Here specify whether holder/repres entativeDelete what is not applicable*	in my/ourDelete what is not applicable* capacity as (2) ………………………………………………. request for a duplicate of the certificate of registration for traditional knowledge/expressions of folkloreDelete what is not applicable* number ……………. for the following reasons:
…………………………………………………………………………………………
…………………………………………………………………………………….……
…………………………………………………………………………………….……
FOR OFFICIAL USE ONLY
Received by: …………………………………………. Officer’s name and signature
Date received: ………………………………………..

FORM XXII

[Regulation 22]

Application No.: ………..

THE PATENTS AND COMPANIES REGISTRATION AGENCY

The Protection of Traditional Knowledge, Genetic Resources and Expressions of Folklore Act
(Act No. 16 of 2016)

The Protection of Traditional Knowledge, Genetic Resources and
Expressions of Folklore Regulations, 2021

APPLICATION FOR AMENDMENT OF DOCUMENT LODGED
TO: THE REGISTRAR:
Details of applicant
(a) Full name
(b) Identity number
(c) Nationality
(d) Residential address
(e) Telephone number
(f) Mobile phone number
(g) E-mail address
*Details of agent (if filed by agent)*
(a) Full name
(b) Identity number
(c) Nationality
(d) Residential address
(e) Telephone number
(f) Mobile number:
(g) E-mail address:
The Registrar is requested by the above named applicant to amend the document stated below: ……………………………………………………………………………………………………………………………..
The following are the details to be amended:
(i) …………………………………………………………………………………………………………………
(ii) …………………………………………………………………………………………………………………
(iii) …………………………………………………………………………………………………………………
(iv) ………………………………………………………………………………………………………………….
Dated this …………… day of ………………. 20…….

……………………………………………. Signature of applicant/holder
FOR OFFICIAL USE ONLY:
Application received by: ………………………………………….. Officer’s name and signature
Date received: ………………………………………………..

SECOND SCHEDULE

[Regulation 24]

PRESCRIBED FEES

No.	Item	Form No.	Foreign fee	ZMW
	TRADITIONAL KNOWLEDGE
1	Application for registration of traditional knowledge	I	N/A	500
2	Notice of application for registration of traditional knowledge	II	N/A	500
	GENETIC RESOURCES
3	Application for access permit	XIII	5,000	1,000
4	Application for an exploration permit	XIII	3,000	1,000
5	Application for renewal of access permit	XVI	5,000	1,000
6	Application for renewal of exploration permit	XVI	3,000	1,000
	EXPRESSIONS OF FOLKLORE
7	Application for registration of expressions of folklore	I	N/A	300
8	Notice of application for registration of expressions of folklore	II	N/A	500
	GENERAL PROVISIONS
9	Appointment of agent	XVIII	1,000	500
10	Application for prior informed consent	VII	5,000	500
11	Application for approval of prior informed consent/access/licensing agreement	IX	1,000	100
12	Notice of objection	III	2,500	1,000
13	Application for a compulsory licence	XI	5,000	2,500
14	Request for information	XIX	350	100
15	Application for duplicate certificate for traditional knowledge/expressions of folklore	XXI	500	500
16	Application for amendment/correction of clerical errors	XXII	500	500

PROTECTION OF TRADITIONAL KNOWLEDGE, GENETIC RESOURCES AND EXPRESSIONS OF FOLKLORE ACT: INDEX TO SUBSIDIARY LEGISLATION

PROTECTION OF TRADITIONAL KNOWLEDGE, GENETIC RESOURCES AND EXPRESSIONS OF FOLKLORE REGULATIONS

PART IPRELIMINARY

PART IIAPPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE

PART IIIACCESS TO GENETIC RESOURCES

PART IVGENERAL PROVISIONS

FIRST SCHEDULE

FORM I

FORM II

FORM III

FORM IV

FORM V

FORM VI

FORM VII

FORM VIII

FORM IX

FORM X

FORM XI

FORM XII

FORM XIII

FORM XIV

FORM XV

FORM XVI

FORM XVII

FORM XVIII

FORM XIX

FORM XX

FORM XXI

FORM XXII

SECOND SCHEDULE

PART I
PRELIMINARY

PART II
APPLICATION FOR REGISTRATION OF TRADITIONAL KNOWLEDGE OR EXPRESSIONS OF FOLKLORE

PART III
ACCESS TO GENETIC RESOURCES

PART IV
GENERAL PROVISIONS