PBSL/GL/012 — Version 03, Rev 02 — English

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar Adopted By PBSL Start of public Consultation End of public Consultation Agreed by QMS committee Approved by Board Pharmacy Board of Sierra Leone PMB 322 Central Medical Stores Compound New England Ville Freetown Page 1 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar Contents 1.0 INTRODUCTION .................................................................................4 2.0 OBJECTIVE: ........................................................................................5 3.0 SCOPE: .............................................................................................5 4.1 SPECIFIC REQUIREMENTS; IMPORTATION OF PHARMACEUTICAL PRODUCTS ...............................................................................................5 MINIMUM REQUIREMENTS FOR THE IMPORTATION OF PHARMACEUTICAL PRODUCTS .............................................................................................. 6 PROCEDURE FOR IMPORTATION OF PHARMACEUTICAL PRODUCTS ................ 7 PROCESSING OF APPLICATIONS BY THE BOARD FOR THE ISSUANCE OF IMPORT PERMIT ....................................................................................... 8 SPECIAL IMPORTATION REQUIREMENTS (EMERGENCIES) ............................. 9 Importation of pharmaceutical products, including medical devices and in vitro diagnostics which have not been granted market authorization............ 9 Importation of medicines and medical devices for personal use ................. 10 Importation of investigational medicinal products or medical devices ......... 10 Importation of controlled drugs ............................................................. 10 Importation of donated drugs ............................................................... 11 Importation of orphan drugs ................................................................. 11 Importation of syringes ........................................................................ 12 CLEARANCE OF IMPORTED CONSIGNMENTS AT THE OFFICIAL PORTS OF ENTRY .................................................................................................. 12 PROCEDURE FOR THE CLEARANCE OF IMPORTED CONSIGNMENTS OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY.............. 14 Page 2 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar 1.0 INTRODUCTION Pharmaceutical products, especially medicines and medical devices have become an integral part of modern healthcare and even daily life. However, their safety, efficacy, and quality can be highly affected by lack of adequate control on the importation and exportation. Globally, pharmaceutical regulation should be improved to ensure that highquality and effective products reach patients and consumers. This is more important in African countries where regulation is a challenge. It is therefore crucial for pharmaceutical companies (manufacturers), importers and wholesalers to understand fully the applicable local regulations so that the manufacture, importation and clearance of pharmaceutical products both nationally and internationally conforms to certain set standards. To strengthen the control of importation and clearance of these products, the Board has developed guidelines to provide importers of pharmaceutical products with the necessary information to enable them to comply with the law and regulations governing importation and clearance of pharmaceutical products into the country. The format of the guidelines is organized into two parts. The first part provides for the requirements and procedures to be followed during importation of pharmaceuticals whilst the second part outlines the requirements and procedures for the clearance of the same. Furthermore, forms and other relevant documents have been appended for easy referencing. The guidelines shall apply to all pharmaceutical products including allopathic Page 4 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar medicines, controlled drugs, donated drugs, medical substances, cosmetic products and nutritional agents. devices, chemical 2.0 OBJECTIVE: To provide importers of pharmaceutical products with the necessary information to enable them comply with the laws and regulations governing the importation and clearance of pharmaceutical products in the country. 3.0 SCOPE: This guideline applies to all importers of pharmaceutical products in the country. 4.1 SPECIFIC REQUIREMENTS; IMPORTATION OF PHARMACEUTICAL PRODUCTS 4.1. CATEGORIES OF IMPORTERS Importers of pharmaceuticals shall fall under the following categories: a) Corporate body duly registered by the Registrar-General’s Department and licensed by the Pharmacy Board. b) Registered Import and wholesale pharmaceutical companies, licensed by the Pharmacy Board. c) Governmental and Quasi- Governmental agencies or Non- Governmental Organizations that run health programs and facilities approved by the Ministry of Health and Sanitation. d) Pharmaceutical Manufacturers e) Clinical trial sponsors and Principal investigators f) Recipients of donations However, the following in the special circumstance can be authorized: Page 5 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar g) Persons authorized to import pharmaceuticals for personal use h) Hospitals authorized to import pharmaceuticals for hospital use MINIMUM REQUIREMENTS FOR THE IMPORTATION OF PHARMACEUTICAL PRODUCTS a) Categories of importers (mentioned in 4.1 above) must first obtain importation license from the office of the Pharmacy Board unless otherwise authorized by the Board before they can embark on the importation of any pharmaceutical product. b) All importers, after obtaining the importation license, must also obtain import permit (i.e., import authorization document) before importing any consignment of pharmaceutical products into the country. c) All pharmaceutical products to be imported must be registered by PBSL unless otherwise authorized by the Board. The details of each product shall be filled in the import permit request form d) All importation of pharmaceutical products must be done by importers whose premises are duly registered by the Board or relevant Government institution. e) All importers must import pharmaceutical products through the authorized Port of Entry (Queen Elizabeth II Quay or Lungi International Airport). f) In case of donations, the importer must have a donation certificate and adhere to the Guidelines for Donations. The donated pharmaceutical products must be fit for human consumption, safe and of good quality and not prohibited in the country of origin. g) No person shall import any pharmaceutical product with shelf life of more than twenty- four months whose remaining shelf life is less than 60% and Page 6 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar a drug with shelf life of less or equal to twenty- four months whose remaining shelf life is less than 80%. h) All imported pharmaceutical products should adhere to the following labeling requirements. i. The information printed on labels must be indelible, engraved or embossed on a primary and secondary container; ii. The immediate outer packaging of the pharmaceutical products should be clearly labeled in English; iii. The trade or brand name where appropriate shall be stated; iv. The International Non-Proprietary Name (INN, Generic name) shall be clearly stated; v. Quantities of active ingredients in the given formulation/API; vi. Date of manufacture and expiry; vii. Batch or Lot number; viii. Storage conditions; ix. Name and address of manufacturer; x. Registration number of the product issued by TFDA in both outer and inner package of the product(s) where applicable; xi. xii. Enclosed and accompanying literature must be in English or Swahili language; API specification (BP, USP, etc.) PROCEDURE FOR IMPORTATION OF PHARMACEUTICAL PRODUCTS a) An authorized importer intending to import pharmaceuticals shall Page 7 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar request for import permit by submitting an application letter and a filled import permit request form (as prescribed under Annex I of these guidelines) to the office of the Registrar. b) The application letter and import permit request form shall be stamped and signed by a registered Pharmacist-in-charge of the importing company before submission to the Board. c) In a situation where section 4.3(b) does not apply, the application letter and import permit request form shall be signed by applicant. d) For NGOs with Gratis, the application submitted should also include attestation letter from the MOHS and a list indicating how the drugs or pharmaceutical products will be distributed (i.e., drug distribution list). e) All applications shall be submitted to the PBSL head quarter office in Freetown, Sierra Leone. PROCESSING OF APPLICATIONS BY THE BOARD FOR THE ISSUANCE OF IMPORT PERMIT a) Upon receipt of the application as specified in 4.3 above, the Regulatory Officer in charge will scrutinize to verify whether all the documentation requirements have been fulfilled. b) If the application meets the prescribed requirements, the applicant will be required to pay an import permit fee of five hundred thousand Leones or its equivalent in the United States Dollars for the import permit to be issued. c) The Board, upon payment of the import permit fee, will issue to the Page 8 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar applicant an import authorization permit as set out in Annex 2 of these guidelines. d) The Board shall indicate the validity of the Import permit (minimum validity of six (6) months is recommended). e) The permit shall not be transferable and will be issued to cover only one shipment for ease of traceability. f) An application will be rejected if it does not meet any of the importation requirements. An applicant will be officially informed clearly stating the reason(s) for the rejection. g) All applications will be processed within three (3) working days with exception of application for importation of products which have not been registered which may take longer to process. SPECIAL IMPORTATION REQUIREMENTS (EMERGENCIES) All application requirements and procedures as prescribed under section 4.3 and 4.4 respectively shall apply. However, in some special circumstances the following requirements will be applicable: Importation of pharmaceutical products, including medical devices and in vitro diagnostics which have not been granted market authorization. An application for importation of the above products should be accompanied by a letter stating reasons for the importation. An import permit will be issued if the following criteria are fulfilled: a) The product submitted is used as sample for registration procedures for the Page 9 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar granting of marketing authorization. The sample should bear a label printed “Free sample – Not for sale” and they should be in a small pack size as compared to commercial pack, and the unit pack should be less than 300. b) The product has been listed by the Board as an orphan or specialized product. Importation of medicines and medical devices for personal use Applications for importation of class B, C and D medicines and/or medical devices for personal or animal use, should be accompanied by a written recommendation from a registered medical practitioner, dentist, veterinary surgeon or any other authorized practitioner. Importation of investigational medicinal products or medical devices Application for the importation of investigational medicinal products or medical devices should be made by a clinical trial sponsor or Principal Investigator for a study approved to be conducted in Sierra Leone. Such applications should be accompanied by Clinical Trial Approval (CTA) letter, Ethical Board Clearance (EBC) and copy of Certificate of Clinical Trial (CCT) issued by the Board. Importation of controlled drugs Application for the importation of controlled drugs should be made by the Pharmacist-in-Charge. Such applications should be accompanied by: a) A copy of current annual license to practice as a Pharmacist. b) Current license of Premises (If private company or establishment). Page 10 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar c) Proforma Invoice of the controlled substances to be imported. d) Any supporting document to request large quantities of controlled substance (e.g., Government Tender Award) e) Pharmacy Board Product Registration Certificate (where applicable). f) Copy of current attestation letter from the Ministry of Health and Sanitation and the drug distribution plan for the controlled substances to be imported (if it is an NGO, Government institution, Bilateral and Multilateral health partners) g) The Distribution Records or Returns of previous imports must be submitted before a fresh application for permit to import can be received (Repeat applications only) A special Import permit for controlled drugs shall be issued to the importer which is valid for 6 months. Importation of donated drugs Applications for importation of donated medicines and/or medical devices for humanitarian purposes should be accompanied by an attestation letter from the MOHS and distribution list indicating how the products will be distributed. Importation of orphan drugs a) Application for the importation of orphan or specialised drugs should be made by the Pharmacist-in-Charge or an authorized importer. Such applications should be accompanied by: i. Samples of the product in the final package ii. Payment of a non-refundable application fee Page 11 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar b) An orphan or specialised drug approved to be imported must first be listed by the PBSL in accordance with the Pharmacy Board Guidelines for the listing of orphan or specialised products (Check with the Drug Evaluation and Registration Department for details). Importation of syringes a) Application for importation permit shall either be for auto disabled (AD) syringes only; or AD and standard disposable syringes and/or type II re-use prevention syringes in a ratio of 90%:10%. The 10% of standard disposable syringes and type II re-use prevention syringes is to cater for specific procedures like nasogastric feeding, blood drawing and delicate aspirations. b) Applications for importation permit consisting of standard disposable syringes and/or type II re-use prevention syringes of nominal capacity of 10ml and below only will not be honored. c) Application for importation of standard disposable syringes and type II re-use prevention syringes of nominal capacity of more than 10ml will be honored without any restriction. d) All types of syringes sterilized by Ethylene Oxide (EO) gas must be packed either in blister pack or ribbon pouch. Syringes packed in polybags are completely not acceptable. It should be noted that polybags are considered not appropriate for EO sterilization and therefore sterility of syringes packed in polybags is not assured. CLEARANCE OF IMPORTED CONSIGNMENTS AT THE OFFICIAL PORTS OF ENTRY Page 12 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar 4.6.1. MINIMUM REQUIREMENTS FOR THE CLEARANCE OF IMPORTED CONSIGNENT OF PHARMACEUTICAL PRODUCTS a) Categories of importers (mentioned in 4.1.1 above) must first obtain import permit or unless otherwise authorized by the Board before they can obtain clearance permit from the office of the Pharmacy Board for their pharmaceutical products to be inspected and released at the official port of entry. b) All importers will be required to apply to the Board for clearance permit, and have a valid import permit issued by the Board before clearing their consignments at the official port of entry. c) All pharmaceutical products to be cleared at the official port of entry must be registered by PBSL unless otherwise authorized by the Board. d) In case of donations, the importer or NGO must be registered with the MOHS and should submit to the Board original copy of attestation letter from the MOHS and drug distribution list. The donated pharmaceutical products must be fit for human consumption, safe and of good quality and not prohibited in the country of origin. e) No person or NGO or Government institution shall import any pharmaceutical product which has expired or with shelf life of more than twenty- four months whose remaining shelf life is less than 60% and a drug with shelf life of less or equal to twenty- four months whose remaining shelf life is less than 80%. Page 13 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar PROCEDURE FOR THE CLEARANCE OF IMPORTED CONSIGNMENTS OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY a) Any authorized importer intending to clear his or her pharmaceuticals at the official port of entry shall request for clearance permit by submitting an application letter for clearance permit. b) The application letter shall be stamped and signed by a registered Pharmacist-in-charge of the importing company before submission to the Board. c) In a situation where section 42(b) does not apply, the application letter shall be signed by the applicant. d) The application letter shall be accompanied by 3 (three) copies of signed import permit that was initially issued, proforma invoice and packing list to the office of the office of the Registrar. The proforma invoice shall state for each pharmaceutical product (including medical device) to be cleared, the following; i. Proforma Invoice number and date; ii. Name and address of the supplier; iii. Name and address of the importer; iv. Name and address of the manufacturer; v. Country of origin; vi. Clear description of items including brand and common names as declared in information of medical devices including in vitro diagnostics submitted to the Authority; vii. The quantity, pack size, unit value, total value in convertible currency; viii. Batch or Lot number; ix. Manufacturing and expiry date; Page 14 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar x. xi. xii. Mode of shipment (sea, air, road); Point of entry; Signature and stamp of the supplier and/or manufacturer responsible for exporting the products; and xiii. Application form which shall be signed by the importer/Pharmacist – in -charge e) All applications shall be submitted to the Pharmacy Board head quarter office in Freetown, Sierra Leone f) All Applications for clearance permits must be submitted at least 21 days before the arrival of the consignment. PROCESSING OF APPLICATIONS FOR THE ISSUANCE OF CLEARANCE PERMIT a) Upon receipt of the application as specified 4.2 (b) above, the Regulatory Officer in charge will scrutinize to verify whether all the documentation requirements have been fulfilled. b) If the application meets the prescribed requirements, the applicant will be required to pay a clearance permit fee of Le 74,000 or Le 100,000 (or its equivalent in the United States Dollars) for QE II quay and Lungi International airport respectively for the clearance permit to be issued. c) The Board, upon payment of the clearance permit fee, will issue to the applicant a clearance permit as set out in Annex 3 of these guidelines. d) The Board shall indicate the validity of the clearance permit (minimum validity of six (6) months is recommended). The permit shall not be transferable and will be issued to cover only one shipment for ease of traceability. e) An application will be rejected if it does not meet any of the requirements Page 15 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar for issuance of clearance permit. An applicant will be officially informed stating clearly the reason(s) for the rejection. f) All applications will be processed within two (2) – four (4) working days with exception of special requests which may take longer period. Inspection of imported consignments at ports of entry On arrival at the ports of entry, pharmaceutical products will be inspected by Pharmacy Board Inspectors to ensure that they comply with the Pharmacy Board’s approved specifications and requirements before they are released. Each consignment must be accompanied by a clearance permit, an original invoice, airway bill or bill of lading. In the case of controlled drugs, the consignment shall also be accompanied by a separate import permit for the importation of narcotic or psychotropic drugs or precursor chemicals. Other government agencies may also conduct inspection activities as the rules and regulations apply. Such agencies may include the Customs/National Revenue Authority (NRA) officer, Police Officer, Clearing Agent and a representative of the port terminal. Sampling of imported products During the process of inspection of the consignment, the Pharmacy Board inspector may decide to sample the imported consignment for further investigation when deemed necessary. The sample collection form (PBSL - F- 74 /02 in Annex 3) will be signed in duplicate by the Pharmacy Board inspectors, Customs/National Revenue Authority (NRA) officer, Police Officer, representative of the port terminal and the Clearing Agent or consignee. Page 16 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar The original filled form will remain with the Pharmacy Board inspector and a copy will be issued to the clearing agent or consignee. Investigation or consultation may take some time before they are concluded, especially where it involves laboratory testing. Where such cases arise, a conditional release will be given to the importer with instructions to store the consignment in his/her warehouse until results of the investigations are out. Verification of the consignment: During verification exercise, the Pharmacy Board inspector may take either of the following actions: a) Authorize release of the consignment. b) The consignment may be put on quarantine at the custom’s or importer’s warehouse pending further investigation. c) Detain the consignment either at customs warehouse or owner’s premises pending further investigation. 4.6.7. RELEASE OR REJECTION OF A CONSIGNMENT AT THE PORT OF ENTRY The Pharmacy Board inspector promptly notify the importer or consignee for detention of imported pharmaceuticals for inspection at the official port of entry. 4.6.8 Release of a consignment: Imported consignments will be released by the Pharmacy Board inspector when satisfied that all importation requirements have been fulfilled. The Pharmacy Board Inspector and the other approved agencies at the port of entry will stamp Page 17 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar with an official stamp marked “APPROVED, PLEASE RELEASE” on the custom’s entry document attached to the clearance permit. At the time of clearing or release, the pharmaceutical product must have a valid shelf life not less than 60 % of the original shelf life. Immediately after the consignment has been released, the original clearance permit issued to the importer is cancelled by the Pharmacy Board Inspector, and this makes the permit no longer valid for any subsequent consignment. For the release of a consignment of perishable pharmaceuticals (e.g. vaccines, immunoglobulins, antisera, oxytocin, etc.) at the official ports of entry, the Pharmacy Board inspectors designated at the port of entry shall have the power to facilitate the immediate release of these products to prevent loss or deterioration in safety, efficacy, and quality by: a) Allowing the release of these products outside normal business hours. b) Giving priority to the perishable pharmaceuticals when scheduling inspections or examinations c) Allowing the perishable pharmaceuticals ( if they have started losing their cold chain) to be moved to importer’s storage facility pending release to avoid further deterioration. d) Providing reasonable reasons to the importer if there is a significant delay for the release of the products. 4.6.9 Rejection of unauthorized consignments at the Port of Entry a) Consignments which do not meet Pharmacy Board’s importation requirements will not be allowed to enter the country and the accompanied Page 18 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar documents shall be stamped with an official stamp marked “DO NOT RELEASE”. b) Pharmaceutical products rejected because of being unregistered or have similar package presentation to a registered product in the country or with unapproved/neutral labelling, upon application may be re-exported to a third country on special request by the importer, and with special clearance from the Drug Regulatory Agency of the country where the consignment is being exported to. 4.6.10 Review and Appeal procedure Any person or institution aggrieved by the decision of the Board in relation to any application for importation of pharmaceutical products may appeal for review of the decision to the Registrar of PBSL within a period of 14 days from the date of receipt of the decision. The Board may review its decision, reject or vary the condition of approval. After reconsideration of the application, if the applicant is not satisfied by the decision of the review, may appeal to the Minister of Health and Sanitation. 5.0 GLOSSARY: Definition of Terms: For the purpose of these guidelines the following terms shall be defined as follows: Act Means the Pharmacy and Drugs Act, 2001 Page 19 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar Applicant Means any person or institution or company that applies formally to get market authorization for one or more pharmaceutical products. Assay Means investigative (analytic) procedure in laboratory for qualitatively assessing or quantitatively measuring the presence, amount or functional activity of a target entity (the analyte). Board Means the Pharmacy Board of Sierra Leone, or its acronym “PBSL” established under section 2 (two) of the Pharmacy and Drugs Act, 2001 Certificate Means a certificate issued by the Board. Clearance permit Means a permit issued to an importer by the Board, authorizing him/her to clear his or her pharmaceutical product(s) at the official port of entry. Consignment Means a quantity of pharmaceutical products supplied at one time in response to a particular request or order. A consignment may comprise one or more packages or containers and may include pharmaceutical products belonging to more than one batch. Container Means any material employed in the packaging of a pharmaceutical product. It could be a bottle, jar, box, sachet, strip, blister or other receptacle which contains the finished pharmaceutical product. Page 20 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar Controlled drug Means any narcotic drug, psychotropic substance or precursor as described under Part VI of the Pharmacy and Drugs Act, 2001. Donation Means an act of presenting pharmaceutical products free of cost to recipients in emergency situations or as a part of development aid in none-emergency situations. Donor Means a governmental or nongovernmental organization or individual who voluntarily donates pharmaceutical products as a donation. In Vitro Diagnostic Medical Device A device, whether used alone or in combination, intended by the manufacturer for the in vitro examination of specimens derived from the human body solely or principally to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software and related instruments or apparatus or other articles. Importer Means a person or institution licensed pharmaceutical product(s) into the country. and/or authorized to import Import permit Means a permit issued to an importer by the Board, authorizing him/her to import pharmaceutical product(s) into the country. Page 21 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar Label Means any tag, brand, mark, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed or impressed on or attached to a container of any pharmaceutical product when it is being supplied. Authorized Representative / Local Responsible Person or Agent A person residing in the country or cooperate body registered in the country who has received a legal mandate from the applicant to act on his behalf with regards to matters pertaining to registration, importation and/or clearance of pharmaceutical products in the country. Manufacturer Means a company that carries out operations such as production, packaging, repackaging, labelling and re-labelling of pharmaceutical products Marketing authorization: A legal document issued by the Board authorizing the sale or distribution of a pharmaceutical product in the country. Medical Device Any instrument, apparatus, laboratory equipment and reagents, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article which is intended by manufacturer to be used, alone or in combination for human beings or other animals for one more of the specific purpose(s) of : a) Diagnosis, prevention, monitoring, treatment or alleviation of diseases or compensation for an injury; b) Investigation, replacement, modification or support or the anatomy or of Page 22 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar a physiological process; c) Supporting or sustaining life; d) Control of conception; e) Disinfection of medical devices; f) Providing information for medical or diagnostic purposes by means of invitro examination or specimens derived from the human body or other animal; and does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means. Pharmaceutical product Any product presented in its finished dosage form, intended for use as a medicine or as a remedy for the purpose of medical, dental or veterinary treatment. It includes medicines, chemical substances, nutritional agents, medical devices, cosmetics and vaccines. Prescription Means a lawful written direction by a medical practitioner, dentist, or veterinary surgeon for the preparation and dispensation of a drug by a pharmacist. Recipient Means a governmental, non-governmental or private health Institution that voluntarily receive pharmaceutical products as a donation. 3.1 ABBREVIATIONS CTA CCT EBC Clinical Trial Approval Certificate of Clinical Trial Ethical Board Clearance Page 23 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar EO MOHS NGO NRA PBSL PoE Ethylene Oxide Ministry of Health and Sanitation Non-Governmental Organization National Revenue Authority Pharmacy Board of Sierra Leone Port of Entry. 6.0 REFERENCES NONE 7.0 ANNEXES ANNEX 1 IMPORT PERMIT REQUEST FORM PBSL - F - 46 - 01 Name of Importer………………………………………………………………………………… Date: ………………………… Address of Importer: ………………………………………………………………………………………………………………… Page 24 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar Name and Contact Address of Manufacturing Company or Exporter: ……………………………………………………………………… Email Address ………………………………….. Route of Import: Air: …………………….. Sea ………………………... Road: ………………………. Reason/Purpose Import: …………………………………………………………………………………………………….. NO. of PRODUCT DOSAGE STRENGTH BATCH PACK QUANTITY DESCRIPTION FORM NUMBER SIZE TO BE (IF IMPORTED AVAILABLE) BRAND GENERIC NAME NAME 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Page 25 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 | Effective date: 17 May 2024 Approved by: Registrar 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. Name and Signature of PRAriMacCiSt: —saccacesecennceeeeeneeneeeeeeeeeeeeeeaeeeeeeeeeeeeeeeeeaseeeeeeGeeeeeeeeeaeeneaeeeeeeeenaeeas ANNEX 2 Page 26 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar PRODUCT IMPORT AUTHORIZATION PERMIT PBSL-F-46/02 Tel: (00 232 Central Medical Stores Compound Fax: (00 232 22) Ville, E-mail: Freetown, Website: www.pharmacyboard.gov.sl Leone Our Ref: …………………………………….. Your Ref: ….………………………………… 22) 024-282886 New England registrar@pharmacyboard.gov.sl Sierra P. M. B 322 Name of Importer: …………………………………………………………………………………………………... Address: ……………………………………………………………………………………………………………… Name of Manufacturer: …………………………………………………………………………………………….. Address: ……………………………………………………………………………………………………………… Name of Exporter: …………………………………………………………………………………………………... Address: ……………………………………………………………………………………………………………… Prepared by: …………………………………………………………………………………………………………. Page 27 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar Country of Origin: ……………………………………………………………………………………………………. NO PRODUCT DESRIPTION BRAND GENERIC NAME NAME PACK SIZE DOSAGE STRENGTH QUANTITY FORM TO BE IMPORED Received by: ……………………………………… ………………………………………………… Page 28 of 35 Approved by:

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar ANNEX 3 CLEARANCE PERMIT PBSL-F-93/01 Ser No: ……… Name and Address of Importer: ……………………………………………………………….. Prepared by: ……………………………………………………………………………………... Port of Entry: ……………………………………………………………………………………... Date Issued: ……………………………………………………………………………………… No: Description of Pharmaceutical Product(s) Page 29 of 35 Dosage form Quantity and strength approved for Importation

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 | Effective date: 17 May 2024 Approved by: Registrar Received DY!.....eceeeeceeseeeeeseeeteeees Approved DY? ........:ceceeeeeeeeeeeeeees Page 30 of 35

GUIDELINES FOR THE IMPORTATION AND CLEARANCE OF PHARMACEUTICAL PRODUCTS AT THE OFFICIAL PORT OF ENTRY .... Rev No: 02 Doc No: PBSL/GL/012 Version no. 03 Issue date: 15 May 2024 Effective date: 17 May 2024 Approved by: Registrar ........................................... ........................................... .. ........................................... ......................................... .... ........................................... Prepared by Reviewed by Head of FIIC Dr Abdulai Kanu Head, Quality Assurance Dr Michael Lahai Page 34 of 35 Approved by Registrar Dr James P. Komeh