The Guideline prepared by the Turkish Medicines and Medical Devices Agency ("Agency") has been updated and published on the official website of the Agency.
Within the scope of the updated Guideline, the regulations regarding the "Source of Supply of Pharmaceuticals Abroad" are explained. These regulations include that the source must comply with certain criteria and details of the documents and authorizations that must be obtained for the supply of products.
The amendments made under the revised Guidelines resulted in some important adjustments to the medicines supply planning rules;
- The first and perhaps the most notable change is that the term "Pharmaceutical Supply Planning Commission" was replaced with "Pharmaceutical Supply Planning Board". This will bring with it some changes in the functioning and structure of the board.
- In addition, the second and third paragraphs of Article 5 were amended;
1. The amendments to the second paragraph of Article 5 are as follows:
- Evaluation criterias for initial drug applications were added. Prior to the amendment, submission of initial drug applications to the Foreign Drug Evaluation Board was only subject to the approval of the Commission for the Evaluation of the Usage of Drugs for Personal Treatment. With the amendment, it is expected that the drug will be examined in terms of the authorities where the drug is authorised, its accessibility in the market and its compliance with the legislative requirements, and it is expected to meet the requirements listed in Article 9 of the Regulation.
- The Board may request all kinds of additional information and documents for examination and, if deemed necessary, may request opinions from the commissions established within the Agency or the relevant public institutions.
- While the former provision of the paragraph stipulated that a notification would be made to initiate the relevant drug research processes after the approval, the amendment stipulates that the relevant drugs may be supplied after the Board approval according to the issues determined by the Agency. In this case, the Agency will not supply the drug itself.
- With the amendment, the provision that the result of the application would be notified to the physician was removed.
2.In the third paragraph of the Article, amendments were made regarding the supply process of medicines that are not available on the market for various reasons despite being authorised in our country. The amendments made are as follows:
- Prior to the Amendment, it was stated to notify drug suppliers to initiate drug research processes according to the provisions of the Regulation, whereas the Amendment stipulates that the relevant drugs may be supplied in accordance with the issues determined by the Agency.
- With the amendment, the provision that the result of the application would be notified to the physician was removed.
- The amendments are not limited to this. As a result of the main amendment made in the second paragraph of Article 13, the phrase 'especially in phase 3 clinical trials' was removed and changed to 'provided that the Agency approves' and the part 'following the authorisation of the study by the Agency' was removed in the section explaining that the reference drug to be used can be provided by foreign pharmaceutical suppliers.
- In addition, in the sixth paragraph of Article 16, the phrase 'In cases where the licensed product is included in the Annex-4/A List of Drugs to be Paid for but is not available/insufficient in the market, the procurement of the drug containing the relevant active substance from abroad can be continued with the decision of the Drug Supply Planning Commission and the Foreign Drug Evaluation Board.' was added and the supply of these drugs from abroad was facilitated.
- Finally, the templates in Annex-2, Annex-3 and Annex-4 were revised. With this amendment, the phrase "in accordance with the Regulation on Procurement of Pharmaceuticals from Abroad and related legislation, which entered into force after being published in the Official Gazette dated 3 February 2023 and numbered 32093" was removed from all annexes.
The full text of the Guideline can be reached via this link. (Only available in Turkish)
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