MEDICINES CONTROL AGENCY 54 Kairaba Avenue, Pipeline, The Gambia. Tel.no. +220 4380632 GUIDELINES FOR REGISTRATION OF IMPORTERS AND FOR THE IMPORTATION OF MEDICINES AND RELATED PRODUCTS Document no: MCA/IMPG/2017/1 Date of issue: 25 th July 2017 Date of adoption: 20 th January 2017 Version no: 01 Page 1 of 10
1. SCOPE In pursuance of Part II Section 4, sub-sections (a), (b) and (f) of the Medicines and Related Products Act 2014, these Guidelines are hereby developed to provide guidance to prospective applicants for registration as an importer and procedures for importing of products into The Gambia. Importers are required to familiarize themselves with this document and this Act before initiating product importation. 2. INTERPRETATION In these guidelines, unless the context otherwise states: - a) Agency means Medicines Control Agency (MCA) b) Applicant: Means a person, manufacturer or company who submits application for registration as an importer and requests for the issuance of an import permit for medicines and related products from the Agency c) medicinal purpose means - use for treating or preventing a disease, diagnosing or ascertaining the presence and extent of a physiological function, contraception, inducing anaesthesia, altering normal physiologic function permanently or temporarily in any way in humans. d) International Non-proprietary Name (INN) means the approved chemical name of the product. e) Generic drug means a finished product based on an active substance that is not off patent and which is marketed under a different name from that of the original branded medicinal product. f) Active Ingredient: Means a substance with a therapeutic, diagnostic or prophylactic activity used in a pharmaceutical product. Drug Substance" and "Active Substance" are synonymous to "Active Ingredient." g) Dosage Form: Formulation of an active ingredient(s) so that it can be administered to a patient in specified quantity/strength eg. tablets, capsules, injection solution, syrups, ointments, suppositories, etc. "Pharmaceutical Form" and "Finished Product" are synonymous to "Dosage Form." h) Counterfeit Medicine: Means a medicine that is deliberately and fraudulently mislabelled with respect to identity for source. Counterfeit products may be branded or generic medicines, and may include products with the correct ingredients, with the wrong ingredient, without ingredients, with insufficient active ingredient, or with fake packaging material. Page 2 of 10
i) Labeling: Includes any legend ( means any description accompanying an illustration), word or mark attached to, included in, belonging to or accompanying any medicine including: 1) The immediate container label 2) Cartons, wrappers and similar items, 3) Information materials such as instructional brochures and package inserts. j) Manufacturer: A company that carries out at least one step of manufacture. k) Medical Device: Means an instrument that is not a medicine, as defined herein, that is intended for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or symptoms thereof, in human or animal, or restoring, correcting, or beneficial modification of organic or mental functions in human or animal. l) Medical Supply: Means article that is intended for diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or symptoms thereof, in human or animal or restoring, correcting or beneficial modification of organic or mental functions in human or animal. This includes suturing materials, syringes, needles, bandages, gauze, cotton, artificial teeth, chemicals, and x-ray film and other similar articles. m) Medicine: Means any substance or mixture of substances intended for use in: (i) the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical or mental state, or the symptoms thereof, in man or animal; or, (ii) restoring, correcting or beneficial modification of organic or mental functions in man or animal; or, (iii) medicine shall include traditional medicine, narcotic drugs, psychotropic substances, blood and blood products, vaccines, sera, and radiopharmaceuticals, but not health products as defined herein. n) Pharmaceutical Importer: Means a registered entity and licensed by MCA to procure and import medicines and related products from foreign countries and/or distribution in the Gambia. o) Related product means an article other than medicine which includes cosmetics, homeopathic medicines, medical device, instrument or apparatus including, components, parts and accessories of it, manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptom of it in man or animal; 3. REQUIREMENTS 3.1 General Requirements 1. Only the following shall be registered as importers and be permitted to import medicines and related products by the Medicines Control Agency (a) Corporate bodies duly registered by the Registrar of Companies Page 3 of 10
(b) Registered wholesale pharmaceutical companies duly licensed by the Agency (c) Governmental (Hospitals, health facilities or similar health related institutions) and Non- Governmental Organizations (NGO s) that provide healthcare services may be permitted to import reasonable quantities on request for use only in their pharmacies and private clinics. (d) Registered Medical doctors, Dentists and Veterinary surgeons may be permitted to import reasonable quantities on special request for use only in their pharmacies and private clinics. (e) Patients with prescriptions for specialist medicines may on request import such medicines for their personal use only. 2. The above notwithstanding, importation of samples for registration, medical promotion, and/or clinical trials, as well as importation of specific prescriptions for particular patients, may be permitted after approval by the Agency. 3. All products imported shall have at least 60% of its shelf-life remaining on arrival at the port. This, notwithstanding, products with a shelf-life of less than 24 months shall have at least 80% of the shelf-life remaining on arrival at the port of entry. 4. Condoms shall be released from the port of entry based on a batch-to-batch evaluation and analysis after approval by the Agency. 5. Products containing steroids are considered as medicines and shall not be permitted to be imported and used as cosmetics. 4.0 PRODUCT IMPORT PERMIT a) Except otherwise provided by these guidelines, import permits shall be granted before the importation of a product. b) In applying for a permit, the following documents shall be submitted: (i) Three (3) copies of the supplier s invoice. (ii) Three (3) copies of appropriately filled permit application forms. c) Permits issued for importation of products shall be presented to Customs ONLY ONCE, and shall not be re-presented for a second time in case goods are short-landed. d) At the point of clearance, the clients copy of the permit should be handed over to the Customs and MCA port inspector for endorsement and clearance of goods. e) For short-landed goods, a new import permit shall be obtained from the Agency. f) Importers registration and Import Permits shall be valid for ONE CALENDAR YEAR from the date of issue. Page 4 of 10
g) Importers registration fees and an import permit processing fee shall be charged as indicated in the Fee Schedule of the Agency. h) Vetting and approval of an application for importation and accompanying pro-forma invoices may take up to five (5) working days i) Permits for importation of controlled drugs, psychotropics and narcotics will be processed only after approval of allocation and submission of returns on consumption. j) Applications which do not conform to any of the requirements of the Agency shall not be approved. 5.0 COMPLETION OF IMPORT PERMIT APPLICATION FORM 5.1 All import permits shall bear the (a) Full name, telephone number, fax, email, postal address and premises address of the exporter and importer (b) Name/description of product (c) Total quantity of product in dosage units (d) Registration number of the product (s) (e) Name of manufacturer/country of origin (f) Batch number (g) Total CIF value (h) Name of port of shipment and approved port of entry and the date 5.2 For MEDICINES, the permit shall bear the following: (a) Full name, signature and registration number of the Superintendent Pharmacist. (b) Brand name and generic name of the product. 5.3 For non-pharmaceutical companies and products, the permit shall be signed by a duly authorized person(s). 5.4 Products imported shall be inspected by officials of the MCA at the port of entry before they are released to the importer. Page 5 of 10
5.5 The above notwithstanding, any statute governing importation procedures and tax liabilities shall apply to an imported product. 5.6 An application for importation of a product may be rejected for several reasons. This may include, but not limited to: (a) A product not registered with the Agency. (b) A product with a potential for abuse (c) A controlled drug, when the national quota for that particular drug is exhausted e.g. narcotic drugs and psychotropic substances. (d) A product found to be counterfeit, fake, substandard and/ or adulterated. 5.7 All importers are required to renew their company import license with the Agency annually. 6.0 SANCTIONS AND PENALTIES 6.1 Non-Compliant Products (a) The Agency may apply the following regulatory actions in case of the importation of a noncompliant product after detention and issuance of appropriate detention notice: (i) Order the re-export of the product at the cost of the importer. (ii) Confiscate a non-compliant product, which may be destroyed and the cost of destruction borne by the importer, who may be prosecuted accordingly. 6.2 Bringing Into Compliance / Rectifying non-compliant products (a) The Agency may permit an importer to bring an imported non-compliant product into compliance with the law. Any sorting, processing, labelling/ re-labelling or analysis shall be supervised by an officer of the Agency at the expense of the importer. (b) Where the non-compliant product is unregistered, the importer shall be made to submit the product for registration and pay the appropriate fees in addition to a penalty to be determined by the Agency. Page 6 of 10
MEDICINES CONTROL AGENCY APPLICATION FORM TO REGISTER AS AN IMPORTER OF MEDICINES AND RELATED PRODUCTS In pursuance of Part II Sections 4 sub-section (b) and (f) of the Medicines and Related products Act 2014 A PARTICULARS OF APPLICANT Name of Company Postal Address Location/Physical Address of Company Contact Details Date of Incorporation of Company Registration number of Company For pharmaceutical companies only Telephone Fax Email website Name of Superintendent Pharmacist Reg. No B Signature ITEMS TO BE IMPORTED (Tick as appropriate) Medicines Allopathic Date Veterinary Homeopathic Page 7 of 10
Herbal Food Supplements Cosmetics Medical Devices Other (Please specify Please attach a copy each of the following documents: i. Certificate of registration from the Registrar of Companies ii. Current Pharmacy Council premise license (For Medicines only). C DECLARATION of APPLICANT I/We, the undersigned, hereby declare that all information contained herein is correct and true. Name: Position/ Designation: Signature: Date:. Official Stamp Page 8 of 10
MEDICINES CONTROL AGENCY IMPORT PERMIT FORM FOR MEDICINES AND RELATED PRODUCTS In pursuance of Part II Section 4 sub-sections (b) and (f) of the Medicines and Related products Act 2014 Name of Importer Postal and Premises Address Name of Exporter Postal and Premises Address Tel Tel Email Name and description (brand, generic name & dosage form) of Product Quantity to be imported MCA Registrat ion Number email Port of Shipment and expected date of Shipment Port of Entry into The Gambia and Expected date of arrival Total CIF Value Page 9 of 10
Name of Superintendent Pharmacist Registration Number Signature OFFICIAL STAMP Name of business owner Signature Date FOR OFFICIAL USE ONLY Vetted by (Name) Signature Designation APPROVED BY Signature OFFICIAL STAMP Executive Director CONDITIONS OF PERMIT 1. Products imported shall be inspected by officials of the Agency at the port of entry before its release. 2. Three (3) copies of the permit together with Three (3) copies of the Supplier s Invoice shall be submitted for approval. 3. Permits issued for importation of products shall be valid for only one transaction. 4. Where goods are short-landed, a new import permit shall be obtained from the Agency. 5. At the point of clearance, the clients copy of the permit should be handed over to the Customs and MCA port inspector for endorsement and clearance of goods. 6. Importers registration and import permits shall be valid for ONE CALENDAR YEAR FROM the date of issue. Page 10 of 10