The Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“) has recently published the Guideline on the Issuance of a “Pharmaceutical Product Certificate,” “Free Sales Certificate” and “Pharmaceutical Product License Status Statement” (“Guideline“) and the Draft Regulation on Permission for Foods for Special Medical Purposes (“Draft Regulation“), and amended the application form within the scope of the Regulation of Marketing Authorization for Pharmaceuticals.
Please click on the relevant link below for our specific notes regarding recent developments:
What does the Guideline on the Issuance of “Pharmaceutical Product Certificate”, “Free Sales Certificate” and “Pharmaceutical Product License Status Declaration” introduce?
What are the Changes in the Application Form within the Scope of the Regulation on Marketing Authorization of Pharmaceutical Products?
The Draft Regulation on Permission of Foods for Special Medical Purposes has been Published
What does the Guideline on the Issuance of “Pharmaceutical Product Certificate”, “Free Sales Certificate” and “Pharmaceutical Product License Status Declaration” introduce?
New Development
In the Guideline published on 11 January 2022, the TİTCK set forth the application conditions, documents, certificates, declaration, samples of name undertakings, and the principles and procedures regarding the preparation of these documents for the issuance of the pharmaceutical product certificate, free sales certificate and pharmaceutical product license status declaration. The Guideline is available here (in Turkish).
What’s New?
As of 1 February 2022, the Guideline covers human medicinal products, traditional herbal medicinal products, foods for special medical purposes and homeopathic medicinal products as well as real and legal persons who have applied for a license and/or been granted a license/permit is in force.
The Guideline sets forth the issues to be considered during the application, such as the requirement to make a separate application for each document, the information to be included in the application letter and the language requirement. Additionally, the information and documents requested in the application are exemplified and the applicants’ responsibility for all the information and documents submitted is regulated.
Pursuant to the Guideline, unless there is a change in the information submitted, the Pharmaceutical Product Certificate and the Free Sales Certificate are valid for two years upon TİTCK’s approval. On the other hand, the Pharmaceutical Product License Status Declaration only represents the current status as of the date of its issuance.
What are the Changes in the Application Form within the Scope of the Regulation on Marketing Authorization of Pharmaceutical Products?
New Development
On 18 January 2022, the TİTCK published an announcement regarding the changes in the license application form within the scope of the recently published Regulation on Marketing Authorization of Pharmaceutical Products and CTD Guidelines. The announcement is available here (in Turkish).
Our legal alert on the changes introduced by the Regulation on Marketing Authorization of Pharmaceutical Products is available online here.
What’s New?
As it is known, various changes have been introduced in the licensing processes within the scope of the new Regulation on Marketing Authorization of Pharmaceutical Products published on 11 December 2021. The pharmaceutical product license application form has been updated according to the amendments. Accordingly, priority assessment, conditional licensing and exceptional licensing applications were added to the application form and a guideline on diversification and related allergen product applications was announced to be published.
In addition, the details of the hybrid application were set forth, and the reference medicinal product is required to contain the same active substances as the hybrid product and be licensed as a complete dossier. Also, the procedures to be followed in cases where additional data is required for hybrid and diversity applications were established.
The Draft Regulation on Permission of Foods for Special Medical Purposes has been Published
New Development
On 26 January 2022, the TİTCK published the Draft Regulation. The Draft Regulation sets forth the procedures and principles to be applied in the issuance of permission certificates and in the works and transactions related to the permitted products in order to ensure the required effectiveness, safety and quality of the relevant products. Opinions on the Draft Regulation can be submitted via tıbbi.beslenme@titck.gov.tr until 24 February 2022. The Draft Regulation is available here (in Turkish).
What’s New?
The Draft Regulation, which covers industrially prepared foods for special medical purposes (tr. “ÖTAG“) and real or legal persons who have applied for or have already been granted a permit, classifies the foods for special medical purposes and regulates the requirements for products developed for infants and children.
In the Draft Regulation, necessary information and documents for permit applications are set forth and marketing of any ÖTAG without TİTCK’s permission is strictly prohibited. The permits will be re-evaluated by the TİTCK after five years from the date of issuance and will become indefinite if renewed.
The Draft Regulation also regulates the procedure for issuing the permit, suspension, cancellation, loss and transfer of the permit. As per the Draft Regulation, the permit holder will be responsible in cases such as, but not limited to, failing to (i) place the product on the market, (ii) produce the product in accordance with the specifications or (iii) update the information on the packaging, if necessary.
Finally, detailed regulations regarding the inner and outer packaging of the products, as well as the symbols and warnings that should be placed on the packaging have been introduced.
Conclusion
The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies should carefully review the TİTCK’s announcements and take necessary actions to ensure compliance.
