Guideline on Import Applications and Marketing Authorization has been Updated
The Guideline on Import Applications and Marketing Authorization (“Guideline“) prepared by the Turkish Medicines and Medical Devices Agency (“Agency“) and entered into force on 29 August 2022 has been updated. The updated Guideline entered into force on 05 June 2023.
The following procedures have been added to the applications that can be made within the scope of the Guideline:
- Issuance of market authorization for blood products or human medicinal products containing blood products, immunological human medicinal products or allergenic products,
- Import procedures of promotional samples of human medicinal products within the scope of the Regulation on Promotional Activities of Medicinal Products for Human Use,
- Notifications of production of non-controlled pharmaceutical raw materials manufactured/to be manufactured domestically by pharmaceutical raw material production site permit holders.
Applications can be made electronically through the Agency’s Electronic Application and Process Management System. However, with the regulation added to the Guideline, it is stated that copies or originals of the application documents must be physically submitted if requested by the Agency.
It is stipulated that import transactions should only be carried out at the customs office of entry selected in the import authorization application form. In addition, if the product is to be imported without packaging, with primary or secondary packaging, and/or in a packaging size that is not the basis for the authorization, it has been made obligatory to specify the packaging size of the product to be placed on the market and the companies where the packaging of the product will be carried out in Turkey in the application petition.
The import notifications must be made within 15 days regarding some products after the import. If the deadline has passed, the reason of the delay should be indicated.
For rejected notifications, a new notification should be filed by adding the necessary information and documents within the scope of the reason for rejection.
The full text of the updated guideline can be accessed via this link. (only available in Turkish)
Tagged with: Moroğlu Arseven, Işık Özdoğan, LL.M., Melis Yılmaz Türköz, Life Sciences, Healthcare
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