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Legislative Proposal on the Amendment of the Law on Pharmaceuticals and Medical Preparations No. 1262 and Certain Laws

The Legislative Proposal on the Amendment of the Law on Pharmaceuticals and Medical Preparations No. 1262, Certain Laws and Decree Law No. 663 (“the Legislative Proposal”) dated March 20, 2023, and numbered 2/5006 is an omnibus bill having some amendment offers regarding the regulating legislation of the health sector.

The Legislative Proposal suggests defining the obligation of registration and notification to the Drug Tracking System at the level of the law, updating the administrative monetary fines defined in the Law, conducting pharmaceutical analysis after-market launch, and accelerating the marketing authorization procedure.

  1. Regulations on the Obligation to Register to the Drug Tracking System

The Drug Tracking System (“ITS”) became operational nationwide by the Ministry of Health in 2010. ITS registration and notification obligations are stipulated in the regulations.

In order to create a basis in the Law for the obligations and the relevant administrative sanctions to be imposed on the violating parties, it is proposed to add an article both to the Law no. 984 on Pharmaceutical Warehouses and Shops Selling Poisonous and Potent Chemical Substances Used in Art and Agriculture and the Law on Pharmaceuticals and Medical Preparations No. 1262 (“the Law No. 1262”) regarding the ITS registry obligation.

  1. Accelerating the Marketing Authorization Procedure

In order to ensure the product safety more effectively and to accelerate the authorization procedure so that the patients can access the medicine they need more quickly, it is proposed that the phrases regarding the request for samples at the authorisation stage be removed from the Law No. 1262, as there is public interest in conducting the analyses performed on the basis of authorization after the authorization of the product and in order to be in line with EU practice.

The Regulation on Licensing of Human Medicinal Products having the effective date of December 11, 2021, prepared in line with the EU legislation states that the marketing authorization procedure will be completed within 210 days. In order to ensure the compliance with international and national practice and the current procedures and principles specified in the secondary legislation, the 2-month period in the Law is abolished and it is stated that these periods will be the ones specified in the current technical regulations.

  1. Removal of the Price Information on Packaging

It is stated that the price of medicinal products may vary in short periods of time during their shelf life, and it is not considered feasible to include the price information on the secondary packaging as fixed price information. It is recommended that the obligation to include the "price" on the packaging be removed.

  1. Update on Administrative Sanctions

The Law No. 1262 does not contain a special provision regarding the increase of administrative sanctions. Pursuant to the relevant provision in the Law on Misdemeanours, administrative monetary fines are increased by the revaluation rate determined and announced in accordance with the provisions of the repeating Article 298 of the Tax Procedure Law for that year, effective from the beginning of each calendar year. However, despite this, it is seen that the amounts close to the current value of the sanctions in the Law no. 1262 have been determined, and the amounts of administrative fines are proposed to be changed in the Legislative Proposal.

In addition, administrative monetary fine for those who sell, distribute or market human medicinal products outside the supply chain stipulated in the legislation or who acts as an intermediary is also provided for the first time with this Legislative Proposal.

Evaluation

The Legislative Proposal aims to update the older legislation in accordance with the Regulation on the Licensing of Human Medicinal Products and other legislation updated in accordance with the EU legislation and to make the legislative arrangements uniform. In addition, regulations have been introduced to eliminate the problems encountered in practice and to meet the needs. The Legislative Proposal was placed on the parliamentary agenda; however, it has not yet passed due to the parliament's recess taken in light of the general elections in Turkey.


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