Transitional period

Any person that, prior to and at the date of commencement of these Regulations, is engaged in commercialisation of any drug or owns a pharmaceutical facility, is, notwithstanding the provision of these Regulations, not required to hold a product licence or facility licence, at any time prior to the 31st October, 2017. provision. __________ Food and Drugs 147 SCHEDULE I FORM 1 [regulation 5(1)] MINISTRY OF HEALTH DRUG REGISTRATION APPLICATION FORM Completion of this form is necessary for consideration for drug registration. Type or print legibly. Application Date Application No. (for official use only) Product Name Product Registration No. (for official use only) Generic Name or International Non- proprietary (INN) name TYPE OF APPLICATION New □ Renewal □ Modification □ PRODUCT LICENSEE INFORMATION Social Security No. Full name Date of Birth Country of birth Permanent Address Street Town District Telephone number Email address 148 Food and Drugs COMPANY’S INFORMATION Business Name Trade License No. Date of issue Place of issue MANUFACTURER INFORMATION Name of Manufacturer Country of Manufacture DOCUMENTS TO BE SUBMITTED WITH APPLICATION FORM No. Document Received (for officiai use only) 1 Ministry of Health Pharmaceutical Wholesaler/lmporter Licence 2 Good Manufacturing Practice Certificale 3 Manufacturer's Sanitary Licence 4 Certificate of Pharmaceutical Product (when applicable) 5 Free Sale Certificate (when applicable) 6 Certificate of analysis 7 Product sample 8 Additional scientific technical information (optional) AFFIDAVIT 1. _____________________________________ (licence holder) declare that the information detailed in this document is truthful and complies with the legal requirements; on the other hand, _________________ (registered chemist and druggist) acting as the professional responsible for the product _______________________________ (product name), declare under oath that the information concerning the name of the product. formulation and therapeutic indications are truthful and guarantee the good quality of the product. Consequently, we declare that this file meets the requirements for registration, so that the data contained in this application, are expression of truth and assume administrative and criminal liabilities. Name and signature of product licensee Name and Signature of Chemist and Druggist Date Food and Drugs 149 FOR OFFICIAL USE ONLY Date received Receiving officer (Name and signature) Assessment officer (Name and signature) Notification sent Assessment comments Date approved/refused Approving Officer Ministry of Health (stamp) LIST OF REQUIREMENTS FOR ASSESSMENT PURPOSES The application form along with required documents should be submitted in a hard covered folder with Documents to be submitted in application form indexed in the same order as it appears in the form. 1. A copy of Ministry of Health Pharmaceutical Wholesaler/Importer Licence should be submitted. 2. A photocopy of a valid Good Manufacturing Practice Certificate. 3. A photocopy of a valid Manufacturer's Sanitary Licence. 4. A “Certificate of a Pharmaceutical Product" (original, not photocopy) bearing information as recommended by the World Health Organisation from the competent health authority in the country of manufacturer certifying that the drug is approved for use and registered in that country and the conditions under which it may be sold in that country. 5. Free Sales Certificate: if the country is not a member of the World Health Organisation certification scheme this certificate must be submitted. 150 Food and Drugs 6. Original copy of the Certificate of Analysis of the product intended to be imported into Belize. 7. A product sample of the finished pharmaceutical form in which it is to be sold. 8. Additional scientific technical information upon request. 9. Official documents such as the Certificates of Pharmaceutical Product should be authenticated by the Belizean Embassy or Belizean Consulate in the country of origin. 10. All documents submitted must be in the English Language or authenticated translation should be bound in a hard cover and correctly indexed in the order presented above for easy reference. 11. The registration fee for each presentation is fifty dollars for new registration or amended modification and twenty five dollars for renewal. This must be made payable to the Treasury Department and the original and a copy of payment should be presented with the application form. 12. All the above requirements must be submitted at the same time to the Office of the Director of Health Services. Incomplete submissions will be returned to the applicant. 13. Request for importation of orphan drug should be done directly to the Office of the Director of Health Services. __________ Food and Drugs 151 FORM 2 [regulation 10(2)] 152 Food and Drugs PLEASE NOTE THE FOLLOWING REQUIREMENTS TO BE SUBMITTED WITH APPLCATION FORM (NEW APPLICANTS) i. Facility floor plan for the business. ii Business certificate registration. iii. Proof of citizenship of application (s) and pharmacist (s) to be employed (notarised birth certificate or passport). iv. Photo Identification of application(s) and pharmacist to be employed (notarised social security or drivers permit) v. Notarised and authenticated original degree, diploma or certificate for all pharmacist (s) to be employed. The final signature of authentication must be that of the Embassy of Belize or British High Commission in that country. vi. Notarised and Authenticated copy of Chemist and Druggist Certificate (for each pharmacist employed) vii. Official translation of all documents to English Language if documents are in any other language. viii. Letter of employment verification between owner and Pharmacist(s) of owner of the facility is not the pharmacist) ix. Proof that applicant is able to read and write English (for those from non-English speaking country) x. For each pharmacist (s) and the owner provide a most recent police record from the Belize Police Department (not older than six months). For foreign applicants. Police Record from country or citizenship (s) and from Belize, if living in the country for less than six (6) months. xi. For each manufacturer the following authenticated and notarised documents must be submitted GMP certificate. CPP or free sale certificate national health authority certificate from the competent authority of the country where the manufacturing plant is, and certificate of analysis. Food and Drugs 153 PLEASE NOTE THE FOLLOWING REQUIREMENTS TO BE SUBMITTED WITH APPLICATION FORM (RENEWAL): i. Copy of most recent approved licence from the Director of Health Services, Ministry of Health. ii. For the applicant, their most recent police record from the Belize Police Department (not older than six months) iii. If any new pharmacist (s) will be recruited at the time of renewal, then step (iii) to step (x) above will be applicable. __________ 154 Food and Drugs SCHEDULE II Application Fees [regulations 10(3)] Application Fees Retail Facility $ 250.00 Wholesale Facility $ 550.00 Importer of Drugs Facility $ 550.00 Manufacturing plant $5,000.00 MADE by the Minister responsible for health this 25th day of July, 2017. (Hon. Pablo Marin) Minister of Health __________