Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 (S.I. No. 58 of 2017)

438 Statutory Instruments 21st July, 2012 IN EXERCISE of the powers contained in section 69 of the Medicines and Allied Substances Act, 2013, the following Regulations are made: Title 1. These Regulations may be cited as the Medicines and Allied Substances (Certificate of Registration) Regulations, 2017. Application 2. A person who intends to operate a pharmacy shall apply to for certificate the Authority for a certificate of registration in Form I set out in the of Schedule upon payment of the prescribed fee. registration Request for 3. The Authority may request an applicant to submit additional additional information, in relation to an application, in Form II set out in the information Schedule. Issue of 4. The Authority shall, where the applicant meets the certificate of requirements of the Act, issue a certificate of registration in Form registration III set out in the Schedule. Rejection of 5. The Authority shall, where it rejects an application, inform application the applicant of the rejection in Form IV set out in the Schedule. Annual return 6. (1) The holder of a certificate of registration shall file with the Authority an annual return or where there has been no change in the information provided in an annual return, a nochange return in Form V set out in the Schedule upon payment of the prescribed fee. (2) The annual return shall cover the period 1st January to 31st December of the preceding financial year and the holder of a certificate of registration shall submit the return or nochange return by 31st March of the following financial year. Transfer of 7. An application for the transfer of a certificate of registration certificate of shall be made in Form VI set out in the Schedule upon payment of registration the prescribed fee. Amendment 8. A holder of a certificate of registration shall, where a change of certificate is made to the registered particulars, notify the Authority within of fourteen days of the change in Form VII set out in the Schedule. registration Suspension or cancellation of certificate of registration Suspension 9. (1) The Authority shall, before it suspends or cancels a or certificate of registration, notify the holder of the certificate of cancellation of certificate registration of the intention to suspend or cancel the certificate in of Form VIII set out in the Schedule. registration (2) Where the holder of a certificate of registration who is notified of the intention to suspend or cancel the certificate of registration under subregulation (1) fails to show cause or does not take any remedial measures to the satisfaction of the Authority 21st July, 2017 Statutory Instruments 439 within the specified time, the Authority shall suspend or cancel the certificate of registration and inform the applicant in Form IX set out in the Schedule. 10. A person whose certificate of registration is cancelled may Application apply for re-registration one year from the date of the cancellation for re- registration of the certificate in Form I set out in the Schedule upon payment of the prescribed fee. 11. (1) A holder of a certificate of registration may apply for Duplicate a duplicate certificate in Form X set out in the Schedule upon certificate of registration payment of the prescribed fee. (2) The Authority may, with fourteen days of receipt of an application under subregulation (1), issue the applicant with a duplicate certificate in Form XI set out in the Schedule. 12. (1) The Authority shall keep and maintain a register of Register of certificates of registration in Form XII set out in the Schedule. certificates of (2) The register referred to in subregulation (1) shall be kept at registration the offices of the Authority and shall be open to inspection by the public at such times as the Authority may determine and upon payment of the prescribed fee.

440 Statutory Instruments 21s July, 2017 SCHEDULE (Regulations 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 and 12) PRESCRIBED FORMS Form I (Regulations 2 and 10) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 APPLICATION FOR A CERTIFICATE OF REGISTRATION OR RE-REGISTRATION Shaded fields Application No. Registration for official use only Date/Time Re-registration Information Required Information Provided — PART I – PARTICULARS OF THE APPLICANT Name of Business (a) PACRA Registration No. (b) TPIN (c) Physical Address: (d) Postal Address: (e) District: (f) Province: (g) Telephone: (h) Fax Number: (i) Mobile: (j) E-mail: PART II – PARTICULARS OF PERSONNEL (a) State the name of the responsible person for the control and management/supervision of the pharmacy. Name of Pharmacist: ……………………………………………………………………………………….......................…… Registration Number: ………………………………………………………………………………………......................……. Signature of responsible person: ……………………………………………………………………………….......................... Date: ……………………………………………………………………………………………………………………............ (b) Name of hospital pharmacy operator (where applicable): ………………………………………………….……………..….. Profession: …………………………………………………………………………………………………………….............. Professional regulatory body: ……………………….…………………………………………………………………….....… Registration Number: …………………………………………………………………………...................…......................... Signature of responsible person: …………………………………………………………………………….......................….. Date: ………………………………………………………………………………………………………................………… PART III – DECLARATION AND SIGNATURE I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. Particulars of the Person Signing on Behalf of the Applicant (a) Name: ……………………………………………………………………………………………………………………... (b) Designation: …………………………………………………………………………………………………………...….. (c) Signature: ……………………………………………… Date: ………/…….…/………………..…….(dd/mm/yyyy) 21st July, 2017 Statutory Instruments 441 No. 1 Valid practicing certificate for the Pharmacist No. 2 Valid practicing certificate for the hospital pharmacy operator (as applicable) No. 3 Letters of agreement or employment contract between the Pharmacist and the company No. 4 Letters of agreement or employment contract between the hospital pharmacy operator and the company (as applicable) No. 5 Sketch of the proposed premises No. 6 Certificate of incorporation or certificate of registration FOR OFFICIAL USE ONLY Date of Submission: ………………………………………………………………………………………… ………………………… Application No.: ………………………………………………………………………………………………….………………..….. Payment Receipt No.: ……………………………………………………………………………………………………………..…… Application Complete (Proceed for inspection): ………………………………………………………………………………....…... Application Deficient (Refer to applicant for additional information): ………………………………………………………..…....... OFFICIAL STAMP

442 Statutory Instruments 21s July, 2017 Form II (Regulation 3) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 REQUEST FOR ADDITIONAL INFORMATION Application No.: ……………… To: ……………………………………………………………………………….....………... Physical address: Plot No: ………………………………………………………………………………..…… Street: ………………………………………………………………………………….…….. Postal address: …………………………………………………………………………....…. District………………………………………………………………………………………. Province…………………………………………………………………………………………………………………. You are requested to furnish, within …………………… days of this Notice, the following information or documents in respect of your application for …………………….....……… (a) …………………………………………………………………………………… (b) …………………………………………………………………………………… (c) …………………………………………………………………………………… (d) …………………………………………………………………………………… (e) ………………………………………………………………………………… If you fail to furnish the requested information within the stipulated period, your application will be treated as invalid and be rejected. Dated this …………. day of ………………………………….., 20…………… OFFICIAL STAMP …………………………..………………….. Director-General 21st July, 2017 Statutory Instruments 443 Form III (Regulation 4) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 CERTIFICATE OF REGISTRATION No.: ……………… This is to certify that (Name of Pharmacy): ……………………………………………………… of (physical address) ……………………………….............................................................…… …………………………………..............................................................................……………. …………………………………………………………………………………………………… is registered as a Pharmacy. The terms and conditions of the certificate of registration are attached herewith. This Certificate is issued on the …… day of ………………………, 20…… ……………………………………….……………….. Director-General Seal (OVERLEAF) TERMS AND CONDITIONS 1. The certificate of registration shall be displayed conspicuously on the premises. 2. The holder of the certificate of registration shall, within 14 days of the changes occurring, notify the Authority of any changes in the ownership, physical address, structure of the place of business, name and location of the pharmacy, change of personnel responsible for the management or control of the pharmacy. 3. The holder of the certificate of registration shall submit annual returns or no change returns by 31st March of the following financial year. 4. The certificate of registration is not transferrable without the written approval of the Authority. 5. Where the certificate of registration is surrendered, the certificate of registration shall be considered cancelled. 6. Where the certificate of registration is cancelled, the holder of the certificate shall surrender it to the Authority. 7. Non-compliance with the terms and conditions of the certificate of registration shall result in the suspension or cancellation of the certificate.

444 Statutory Instruments 21s July, 2017 Form IV (Regulation 5) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 NOTICE OF REJECTION OF APPLICATION 1. Here insert TO (1) ……………………………………………………….................……….. the full names …………………………………………………………………………………………….. and address of the applicant ………………………………………………………………………...……………………. 2. Here insert IN THE MATTER OF (2) …………………...........……........…………….. the reference No. of the You are hereby notified that your application for (3) ………………… has application been rejected on the following grounds: 3. Here insert type of application (a) ………………………………………………………………................... (b) ………………………………………………………………….........….. (c) …………………………………………………………………............ (d) ……………………………………………………………….. Dated this …………………………….. day at ………………….. 20 …….. …………………………….. Director-General OFFICAL STAMP 21st July, 2017 Statutory Instruments 445 Form V (Regulation 6(1)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 ANNUAL RETURN ( ) NO CHANGE RETURN ( ) PART I: PARTICULARS OF CERTIFICATE HOLDER Name of business: ………………………………………………………………Certificate of Registration No……………………………… Date of Issue……………………………...… Name of Pharmacist/Responsible person………………………………………………..…... Name of business: ……………………………………………………………………………………………………… Certificate of Registration No……………………………… Date of Issue…………………………………..…… Name of Pharmacist/Responsible person………………………………………………..……………………….. PART II: DETAILS OF RETURN Type of Return* Annual Return No Change Return Period of Return: 1st January 20………………….….. to 31st December 20…....…...... Date of Submission ……………………..………, 20………. * Tick as applicable PART III: SUMMARY OF CHANGES (Not applicable if there is no change) No. Type of Change Previous Details New Details (e.g. ownership, pharmacist, Location etc.) 1. 2. 3.

446 Statutory Instruments 21st July, 2017 I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. Particulars of the Person Signing on Behalf of the Applicant (a) Name: ………………………………………………………………………………………………………………………. (b) Designation: …………………………………………………………………………………………………………..….. (c) Signature: ………………………………………………… (d) Date: …/……/……….….(dd/mm/yyyy) FOR OFFICIAL USE ONLY Date of Submission: ……………………………………………………………………………………………………………… Application No.: ………………………………………………………………………………………………………….……… Payment Receipt No.: …………………………………………………………………………………………………………… Application Complete (Proceed for Evaluation): ……………………………………………………………………………… Application Deficient (Refer to applicant for additional information): …………………………………………………… OFFICIAL STAMP 21st July, 2017 Statutory Instruments 447 Form VI (Regulation 7) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 APPLICATION FOR TRANSFER OF CERTIFICATE OF REGISTRATION Shaded fields Application No. for official use only Date/Time Information Required Information Provided — PART I – DETAILS OF CURRENT CERTIFICATE HOLDER 1. Name of Business (a) PACRA Registration No. (b) TPIN (c) Physical Address: (d) Postal Address: (e) District: (f) Province: (g) Telephone: (h) Fax Number: (i) Mobile: (j) E-mail: PART II – DETAILS OF PROSPECTIVE CERTIFICATE HOLDER 2. (a) PACRA Registration No. (b) TPIN (c) Physical Address: (d) Postal Address: (e) District: (f) Province: (g) Telephone: (h) Fax Number: (i) Mobile: (j) E-mail: PART III – DECLARATION AND SIGNATURE I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. Particulars of the person signing on behalf of the Applicant (a) Name: ………………………………………………………………………………….…………………………… (b) Designation: ………………………………………………………………………………………………………. (c) Signature: ……………………………………………………………………………..…………………………….. (d) Date: ………/…….…/………………..…….(dd/mm/yyyy) PART IV - ENCLOSURES Evidence of transfer between certificate holder and the prospective certificate holder FOR OFFICIAL USE ONLY Date of Submission: …………………………………………………………………………………………………………..……… Application No.: ……………………………………………………………………………………………….…………….....…….. Payment Receipt No.: ………………………………………………………………………………………………………………… Application Complete (Proceed for Evaluation): ……………………………………………………………………………………... Application Deficient (Refer to applicant for additional information): …………………………………………………………………. OFFICIAL STAMP

448 Statutory Instruments 21st July, 2017 Form VII (Regulation 8) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 NOTIFICATION OF AMENDMENT OF CERTIFICATE OF REGISTRATION PART I: PARTICULARS OF CERTIFICATE HOLDER Name of business: ………………………………………………………………………………………………… Certificate of Registration No.: ……..……………………………… Date of Issue………………………………. Name of Pharmacist/Responsible person…………………………………………………………………………… PART I: PARTICULARS OFAMENDMENT No. Description of amendment(s) 1. 2. 3. SUMMARY OF THE AMENDMENT EXISTING PROPOSED DATE OF REASONS FOR (Name of pharmacist, AMENDMENT AMENDMENT AMENDMENT physical address etc) PART III: SUPPORTING DOCUMENTATION Please submit documents, where applicable, to support your application for amendment. PART IV: DECLARATION AND SIGNATURE I declare that all the information I have stated is correct and truthful to the best of my knowledge and belief. Particulars of the Person Signing on Behalf of the Applicant (a) Name: ……………………………………………………………………………………………….…………………. (b) Designation: ………………………………………………………………………………..……………………….. (c) Signature: ……………………………………..…… (d) Date: ……./…….…/……………..…. (dd/mm/yyyy) 21st July, 2017 Statutory Instruments 449 FOR OFFICIAL USE ONLY Date of Submission: ………………………………………………………………………………………………………… Application No.: …………………………………………………………………………………………………….……… Payment Receipt No.: ……………………………………………………………………………………………………… Application Complete (Proceed for Evaluation): …………………………………………………………………………… Application Deficient (Refer to applicant for additional information): ……………………………………..……………… OFFICIAL STAMP

450 Statutory Instruments 21st July, 2017 Form VIII (Regulation 9(1)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 NOTICE OF INTENTION TO SUSPEND OR CANCEL CERTIFICATE OF REGISTRATION Certificate of Registration No.: ……….. To: ................................................................................................................................. ........................................................................................................................................ IN THE MATTER OF ..................................................you are hereby notified that the Authority intends to *suspend ( ) cancel ( ) your certificate of registration on the following grounds: (a) ..................................................................................................................................... (b) ..................................................................................................................................... (c) .................................................................................................................................... (d) .................................................................................................................................... Accordingly, you are requested to show cause why your certificate of registration should not be suspended/cancelled and to take action to remedy the breaches set out in paragraphs ......................... (above) within ................ days of receiving this notice. Failure to remedy the breaches shall result in the *suspension / cancellation of your certificate of registration. Dated this.................... day of ........................................, 20............... ............................................... Director-General OFFICIAL *Delete as applicable STAMP 21st July, 2017 Statutory Instruments 451 Form IX (Regulation 9(2)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 NOTICE OF SUSPENSION OR CANCELLATION OF CERTIFICATE OF REGISTRATION Certificate of Registration No.: ……………….. To: .......................................................................................................................................... ............................................................................................................................................... IN THE MATTER OF ..................................................you are hereby notified that your certificate of registration has been suspended for a period ……………/cancelled on the following grounds: (a) .................................................................................................................................. (b) ................................................................................................................................... (c) ................................................................................................................................... (d) ................................................................................................................................... In case of cancellation, you are required to surrender the certificate of registration to the Authority within seven days from the date of cancellation. Dated this ...................... day of ........................................, 20............... ............................................... Director-General OFFICIAL STAMP *Delete as applicable

452 Statutory Instruments 21st July, 2017 Form X (Regulation 11(1)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 APPLICATION FOR DUPLICATE CERTIFICATE OF REGISTRATION Shaded fields for official Application Please complete in block letters use only No. Date and Time Information Required Information Provided — PART I: PARTICULARS OF THE APPLICANT Name of Business: Address: (a) Physical Address: (b) Postal Address: (c) Province: (d) District: Contact details (a) Telephone No.: (b) Fax No.: (c) Mobile phone No.: (d) Email address: PART II: PARTICULARS OF PROPRIETOR(S)/DIRECTOR (S) No. Full Names Sex Nationality Residential Date of NRC/Passpo Address Birth rt No. 1. 2. 3. 4. 5. 6. PART III: REASONS FOR APPLICATION 1. 2. 3. PART IV: SUPPORTING DOCUMENTATION Submit an affidavit of loss, destruction or otherwise of original certificate of registration 21st July, 2017 Statutory Instruments 453 PART V: DECLARATION DECLARATION AND SIGNATURE I declare that the information I have stated is correct and truthful to the best of my knowledge and belief. Particulars of the person signing on behalf of the Applicant (a) Name: …………………………………………………………………………………………………….…… (b) Designation: …………………………………………………………………………………………………… (c) Signature: ……………………………………………………………………………………………………. (d) Date: …………………./…………./……………………………………………. (dd/mm/yyyy) FOR OFFICIAL USE ONLY Date of Submission: ……………………………………………………………………………………….………..… Application No.: ……………………………………………………………………………………….………………. Payment Receipt No.: ………………………………………………………………………..………………………… Application Complete (Proceed to issue) ……………………………………………………………..……………… Application Deficient (Notify applicant on deficiencies): ……………………………………………………………… OFFICIAL STAMP

454 Statutory Instruments 21st July, 2017 Form XI (Regulation 11(2)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 DUPLICATE CERTIFICATE OF REGISTRATION No.: …………… This is certify that (Name of Pharmacy) ……………………………………………………….. ……………………………………………………………………………………………………………..… of (physical address) ………………………………………………………………………….… …………………………………………………………………………………………………………………..… is registered as a Pharmacy. The conditions of the certificate of registration are attached herewith. This certificate is issued on ……..……. day of ………………………., 20…….. …………………………………… Director-General Seal 21st July, 2017 Statutory Instruments 455 Form XII (Regulation 12(1)) The Medicines and Allied Substances Act, 2013 (Act No. 3 of 2013) The Medicines and Allied Substances (Certificate of Registration) Regulations, 2017 REGISTER OF CERTIFICATES OF REGISTRATION No. Name and Address of Certificate Number Date of Issue Date of Pharmacy Suspension/Cancellation 1. 2. 3. 4. 5. 6. 7. DR C. CHILUFYA, Minister of Health LUSAKA 14th July, 2017 [MH/71/3/8 TJ]

456 Statutory Instruments 21st July, 2017