Raw Material and Manufacturer Approval Procedure

Transcription

1 Raw Material and Manufacturer Approval Procedure National Health Regulatory Authority (NHRA) Kingdom of Bahrain May 2018 Version 1 1

2 1. Introduction This document is meant to provide assistance to industry and professionals on how to comply with governing statutes and regulations. The document also provide assistance to staff on how NHRA mandates and objectives should be implemented in a manner that is fair, consistent and effective. NHRA approval is mandatory, prior to import of raw materials by an authorized/licensed local manufacturing facility in the Kingdom of Bahrain. An approval for import of raw material (along with their manufacturing source), to be used in the manufacture of finished pharmaceutical product is required. It should be noted that the NHRA has the right to request any information and data within the context of this procedure. This document should be read in conjunction with other applicable guideline documents. 2. General notes: The objective of this document is to define the procedure for approval of raw material and its manufacturer. Listed below are few of the instruction vital for approval process: 1. It is the responsibility of the applicant to ensure that all of the information given in the approval checklist and supporting documents are true and valid. 2. Applicant is also responsible for the quality and safety of the product once approved. 3. Raw material and its manufacturing source approval is valid for 3 years. 4. Respond to NHRA queries or requests for more data for review, within the timelines to avoid closure/rejection of the application. 5. Only five manufactures will be approved for each raw material. Failure to comply with the above shall render the issued approval letter cancelled. 3. Submission & Documentation In order to submit new application, the applicant must request an appointment to the concerned staff in PPR department by . Appointments are assigned on a first-come basis. On the appointment day NHRA staff will check the file to make sure all the requested documents are available only valid applications will be accepted. I. List of documentations required for Active Pharmaceutical Ingredients (API): 2. Valid legalized GMP certificate from the API manufacturing site. 3. Valid legalized manufacturing license of the API manufacturing site. 4. Letter of access from the API manufacturing site. 5. Active substance master file on CD. 2

3 6. If applicable complete certificate of suitability issued from European Directorate for Quality of Medicines (EDQM) along with a declaration that the information submitted is same as the active substance master file. 7. If applicable letter of access to closed part. 8. Alcohol content declaration. 9. Porcine content declaration. 10. TSE free declaration or certificate of suitability. 11. List of countries the API is exported. Note: All the above documents must be submitted on a CD, excluding legalized documents. II. List of documentations required for Excipients: 2. Valid legalized manufacturing license of the excipient manufacturing site. 3. Letter of access from the excipient manufacturing site. 4. Excipient master file on CD. 5. If applicable, complete certificate of suitability issued from European Directorate for Quality of Medicines (EDQM) along with a declaration that the information submitted is same as the excipient master file. 6. If applicable letter of access to closed part. 7. List of countries the excipient is exported. 8. Alcohol content declaration. 9. Porcine content declaration. Note: All the above documents must be submitted on a CD, excluding legalized documents. 4. Assessment and Queries Each application is assessed in accordance with relevant International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) quality guidelines. In cases where queries arise, a request for further information will be sent to the applicant. The applicant is requested to respond to such requests in a timely manner and in accordance with any decided timeline. NHRA will not be held responsible for the delay of approval process, if the applicant fails to respond to NHRA request in a timely manner. Prior to approval, NHRA reserves the right to analysis the raw material in laboratory, if applicable request for laboratory analysis will be sent to the applicant. Failure to respond to NHRA request for information will result in rejection of the application. 3

4 5. Approval Approval letter is valid for 3 years. NHRA reserves the right to cancel or withdraw the approval for any raw material if found noncompliant during its lifecycle after approval. Approval of active ingredient/excipient and its manufacturer with NHRA, do not circumvent the need for finished product registration. As per the Bahrain Pharmacy law 18 of 1997, pharmaceutical product must be registered with NHRA prior to its export, sale and distribution in Kingdom of Bahrain. 6. Importation and clearance Importation and clearance of raw material will be through NHRA invoice clearance procedure. 7. Renewal An annual report for the DMF should be filed after every three years, if the no annual report is filed NHRA has the right to consider it inactive. In cases where there is on change to the DMF, the applicant must submit a no change declaration every three years. 4

5 Annex I Raw Material and Manufacturer Approval Checklist Application Number Application Date Active Ingredient /Excipient name Agent Local Company name (Applicant) Manufacturer name 2. Legalized GMP certificate from the API manufacturing site. 3. Legalized manufacturing license of the API /Excipient manufacturing site. 4. Letter of access from the API/ Excipient manufacturing site. 5. Active substance master file on CD. 6. Excipient master file on CD. 7. Complete certificate of suitability of European Pharmacopeia, if applicable. 8. Letter of access to closed part, if applicable. 9. Alcohol content declaration. 10. Porcine content declaration. 11. TSE free declaration or certificate of suitability. 12. List of countries the API/Excipient is exported. For internal use only I declare that I have received the documents as outlined in the above checklist. Name : Date : Signature : Comments : 5