New Regulation on Named Patient Programs is Published
Pharmaceuticals that are not authorized in Turkey and/or not available in the market despite being authorized, shall be procured from abroad upon request of physicians and special authorization in cases where patients require such pharmaceuticals. Until recently, this exceptional import regime for pharmaceuticals was regulated by the Guideline on the Supply of Pharmaceuticals from Abroad published by the Turkish Medicines and Medical Devices Agency ("Agency").
On February 3, 2023, the Regulation on the Supply of Pharmaceuticals from Abroad ("Regulation") was published in the Official Gazette numbered 32093, and the former Guideline was abolished.
The Regulation aims to register the persons and institutions involved in the procurement process and to ensure the traceability of procured pharmaceuticals. On the other hand, since the Regulation refers to new guidelines to be issued by the Agency on many issues, it is important to wait for the guidelines to clarify the details of the practice. The notable new provisions in the Regulation are summarized below.
i. The Foreign Pharmaceutical Supply Source and Conditions of Supply from Abroad
For the first time, the Regulation introduces the term "Foreign Pharmaceutical Supply Source" ("Source") in the legislation. The Regulation defines the Source as a foreign institution or organization that supplies medicinal products for human use to authorized institutions in Turkey and regulates from where and under what conditions the Source may procure them.
In terms of the products licensed by the competent medicines authorities that are founding or permanent members of the ICH (International Council for Harmonization), the MHRA (United Kingdom Medicines and Healthcare products Regulatory Agency), or the TGA (Therapeutic Goods Administration of Australia), by the Source. The supply of products placed on the domestic market of these countries can only be made directly from the manufacturer/marketing authorization holder companies or pharmaceutical warehouses authorized by the competent authority in the relevant country. The supply of products from the domestic market of any country other than these countries can be carried out by submitting a declaration of the manufacturer/marketing authorization holder company, which undertakes that the product series in the country from where the product will be supplied are safe and in compliance with good distribution practices (GDP).
- In terms of the products that have not been authorized by the competent medicines authorities that are founding or permanent members of the ICH, the MHRA, or the TGA may only be supplied by the Source from the manufacturer/marketing authorization holder companies to ensure quality, efficacy, and safety conditions and to prevent counterfeit/smuggled products. Imports of human medicinal products procured by the Source within this scope into Turkey must be made directly from the relevant country.
- ii. Obligation to Appoint a Resident Representative in Turkey
Since the Source shall not be a local resident, a real or legal person resident in Turkey must be authorized in writing to fulfil the Source’s obligations on its behalf. This person is defined as the Representative.
The Representative must provide the necessary information and documents to the relevant suppliers in Turkey during the procurement process. It is regulated that the Source can appoint a "Foreign Pharmaceutical Supplier", who will supply the product, as the Representative if it meets the conditions.
It is stated that the details regarding the appointment of a Representative and an example of a contract regarding the appointment of the Representative may be published by the Agency. The effective date of the obligation to appoint a representative has been determined as one month after the Regulation's publication, namely, March 3, 2023.
iii. Responsibilities of the Foreign Pharmaceutical Suppliers
Human medicinal products can only be supplied from the Source by organizations identified as Foreign Pharmaceutical Suppliers ("Suppliers"). Suppliers are public institutions and organizations deemed appropriate by the Ministry of Health, the Social Security Institution ("SGK"), and the Turkish Pharmacists Association ("TEB").
There is no additional explanation in the Regulation regarding the public institution and organization deemed appropriate by the Ministry and no announcement has been published yet.
The Regulation imposes similar obligations on Suppliers regarding product supply, storage, and distribution conditions as those set out for pharmaceutical warehouses in other regulations.
Furthermore, it has been regulated that Suppliers must have a permit issued by the Agency in line with the provisions of the Law No. 984 on Pharmaceutical Warehouses and Shops Selling Poisonous and Potent Chemical Substances Used in Art and Agriculture and the regulation on the implementation of this law. In this context, Suppliers are obliged to operate per the Good Distribution Practices, to have an agreement with a facility for secondary packaging for the products they supply, and to make individual notifications of the products.
The effective date of this obligation has been determined as six months after the Regulation's publication, namely August 3, 2023.
iv. Obligation to Register the Products in the Pharmaceutical Tracking System
To ensure the traceability of the human medicinal products supplied, the Suppliers must make individual tracing notifications to the Pharmaceutical Tracking System ("ITS") for each product supplied from abroad.
QR code application and ITS notifications must be fulfilled for the products supplied within the scope of the Regulation on Packaging Information, Instructions for Use, and Tracking of Medicinal Products for Human Use. These procedures must be carried out through secondary packaging facilities authorized by the Agency under the Regulation on Manufacturers of Medicinal Products for Human Use.
The effective date for this obligation has been determined as three months after the Regulation's publication, namely, May 3, 2023
Allegations of irregularities and supply of counterfeit drugs subject to NPP were recently reported in the news and seems to have accelerated the need of regulating this exceptional drug supply regime at a higher level of legislation and resulted in establishing a more accountable system and detailing the obligations of responsible persons with a Regulation.
All the measures introduced will ensure registration, control, and monitoring of the importation of medicinal products on a prescription basis and will create a control mechanism similar to the authorized medicinal products. However, the fact that the supply of products can be made not only from the manufacturers but also from pharmaceutical warehouses might not eliminate the risk of counterfeit pharmaceuticals and may also cause various concerns regarding parallel imports.
In addition, the periods provided by the transitional provision of the Regulation may not be sufficient for the Source or Suppliers to update their contractual relationships or establish a new one.
The Turkish version of this article is available on Yurt Dışından İlaç Temini Yeni Yönetmelik ile Düzenlendi
Tagged with: Gün + Partners, Fatma Sevde Tan, Dicle Doğan, Life Sciences & Healthcare