Click the button to listen to our legal alert now!
The Ministry of Health (“Ministry”) published the Regulation on Pharmaceutical Businesses and Products in the Pharmaceutical Businesses (“Regulation”) in the Official Gazette on 15 June 2022.
What does the Regulation Introduce?
The Regulation sets forth the procedures and principles regarding the purchase, sale, storage, brokerage, distribution, export and transportation of products and active substances in accordance with good distribution practices and relevant national and internationally accepted standards.
The Regulation is available online here.
New Developments
The Scope
The Regulation covers the personnel and businesses where activities of export and transportation, purchase, sale, storage, brokerage and distribution of pharmaceutical business products and drug substances are conducted. and which have been/ will be operating pursuant to Law No. 984 on Pharmaceutical Businesses and Agricultural and Active Chemicals Shops and Law No. 1262 on Pharmaceutical and Medical Preparations.
Supply Chain
Products and active substances are required to be moved within the scope of the legal supply chain consisting of persons, institutions and organizations that are licensed/permitted/authorized and that carry out the purchase, sale, export, storage, brokerage, distribution or transportation of products and active substances.
Unlicensed, counterfeit, expired, defectively manufactured, modified, spoiled, withdrawn or suspected products which cannot be sold, must be reported to the Turkish Pharmaceuticals and Medical Devices Authority (“TİTCK“). Upon certain examinations on the Pharmaceutical Track System (İTS), the TİTCK takes necessary precautions to avoid these products’ entry to the supply chain. These measures cover taking the products to a separate and locked area physically as well as terminating the sale of such products electronically. If necessary, the TİTCK can also carry out an inspection.
Transfer centers, commissioners and pharmaceutical businesses
- The Regulation regulates the transfer center and commissioners and re-describes the pharmaceutical warehouse in the abolished Regulation on Pharmaceutical Warehouses and Products in Pharmaceutical Warehouses as pharmaceutical business.
- Transfer center refers to temporary storage centers where products and active substances can be stored for a maximum of 72 hours provided that necessary precautions on the storage conditions are taken. In transfer centers products must be stored in clean, appropriate and safe conditions and their shipping packaging should not be damaged.
- In the transfer centers, a responsible personnel who has an associate/undergraduate degree and a personnel permit issued by the TİTCK must be actively present during the service hours. Procurement of services from transfer centers does not lift the responsibility of the pharmaceutical businesses.
- Commissioners are the persons who only mediate the activities related to the sale or purchase of licensed/permitted products and active substances. Commissioners cannot distribute, take ownership of and physically handle the licensed/permitted products and active substances, or sell them on their own behalf or by proxy.
- Pharmaceutical businesses should have suitable conditions, materials and personnel to ensure that products and active substances are stored and distributed under the necessary storage conditions.
- The medicine determined by the TİTCK must be available in sufficient quantities for at least 3 pharmacies in the province where a pharmaceutical business distributes to pharmacies.
- Pharmaceutical businesses cannot engage with the activities other than the ones registered in their permit. They also cannot use any facilities other than the address registered in the permit. However, they can open branches upon permission to be obtained by the TİTCK.
- Pharmaceutical businesses can carry out export activities by reporting via İTS and can procure products and active substances, except drugs and psychotropic or precursor substances, from licensed/permitted persons and pharmaceutical businesses. Pharmaceutical businesses cannot engage in manufacturing activities such as dividing, shredding, repackaging. Pharmaceutical businesses located in free zones are also subject to the abovementioned obligations.
Permit application
- Those who want to operate as a pharmaceutical business, transfer center or commissionner must obtain permission from the Provincial and District Health Directorates (“Directorate“). The Directorate shall carry out an on-site control within 15 days Upon application of the relevant persons along with the information and documents set forth under the Regulation. As a rule, for commissioners an evaluation is made on the file without performing an on-site control, however the TİTCK can decide to conduct a control if necessary. If non-compliance is detected during the control, this situation will be reported to the applicant to ensure compliance. The application submitted will be evaluated by the TİTCK maximum within 90 days.
- If the application is accepted, a permit certificate, responsible director certificate or a responsible personnel permit is issued to the pharmaceutical business and transfer centers based on their activities.
- Changes in the information provided in the permit, responsible director certificate or responsible personnel permit must be notified to the TİTCK.
Transition period
- Pharmaceutical businesses who have obtained license prior to 15 June 2022, must ensure that their permit certificates are in compliance with the Regulation within eighteen months from 15 June 2022.
- Pharmaceutical businesses where the dividing, shredding and repackaging processes of the active substances and products used in the production of magistral drugs are carried out must obtain permission in accordance with the Regulation on Human Medicinal Product Factories within twelve months from 15 June 2022.
Sanctions
- Upon expiry of the period granted to the permit holders based on the nature of the deficiencies detected during inspections, if the deficiencies are not corrected, an administrative fine may be imposed in addition to the sanctions of termination of the activity, suspension of the permit completely or partially or cancellation of the permit.
- The documents of the responsible directors of the businesses that are found to be violating the Regulation; the permits of the responsible personnel may be suspended or completely cancelled. In addition, product movements and notifications can be terminated by the TİTCK through the İTS.
The Regulation entered into force on 15 June 2022 and repealed the Regulation on Pharmaceutical Warehouses and Products in Pharmaceutical Warehouses.
Conclusion
The Regulation repealed the Regulation on Pharmaceutical Warehouses and Products in Pharmaceutical Warehouses and introduced new regulations regarding storage and transportation. The Regulation also introduced the concepts of supply chain, transfer center and commissioner. All relevant real persons and legal entities operating in the health sector should closely follow the regulations and fulfill their obligations in accordance with the requirements set forth by the Ministry and the TİTCK.
