Regulation on Market Control of Human Medicinal Products and Foods for Special Medical Purposes

The Regulation on Market Control of Human Medicinal Products and Foods for Special Medical Purposes, published in Official Gazette No. 32729 of 21 November 2024, sets the procedures, powers and responsibilities for planning, carrying out and evaluating the market control activities that keep products licensed or authorised by the Turkish Medicines and Medical Devices Agency (the Agency) at the required level of efficacy, safety and quality on the market (Article 1). It is based on Law No. 1262 (Article 3) and repealed the Regulation on Market Control of Human Medicinal Products published in Official Gazette No. 32208 of 1 June 2023 (Article 10).

Which products does market control cover?

The scope includes licensed or authorised human medicinal products, the active substances used in making them and foods for special medical purposes. Magistral medicines, meaning medicines prescribed by a physician for a patient and prepared in a pharmacy, are excluded (Article 2). The Regulation places products already on the market under periodic control programmes, according to the separate licensing regulations for human medicinal products, traditional herbal medicinal products, homeopathic medicinal products and foods for special medical purposes (Article 6(1)).

How is it decided which products are checked?

The programme is prepared by the nine-member Market Control Planning Board within the Agency (Article 5). The Board weighs risk parameters, such as national or international notifications and pharmacovigilance data, the level of good manufacturing practice compliance of the production site, whether the product has previously been recalled and in which class, recall data from countries where it is licensed, inspectors’ recommendations, and the pharmaceutical form and whether the product is sterile or biological (Article 6(2)). Samples are taken from different points of the legal distribution chain using Pharmaceutical Track and Trace System (İTS) data, while active-substance samples are obtained directly from the production site (Article 6(5)).

The marketing authorisation or permit holder of a product included in the programme must send the specifications, analytical methods and validation information completely to the National Control Laboratory within the period set by the Agency; for active substances this duty lies with the holder of the production-site permit (Article 6(6)-(7)). The National Control Laboratory is responsible for receiving samples, analysis and reporting, and its fee is collected from the holder (Article 7).

What happens if a non-conformity is found?

If analysis results show that a product or active substance is not satisfactory, an assessment is made under the Recall Regulation. If a recall decision is taken, the holder is told to carry out the necessary steps and the Agency acts under Articles 18 and 20 of Law No. 1262 (Article 8(1)-(3)). If production of a defective product continues despite the Agency’s warnings, the provisions of the relevant licensing regulations apply (Article 8(4)).

Following a risk assessment, or if specification information is not provided, the Agency may block the product’s placing on the market or presence on the market through İTS (Articles 6(4) and 8(5)). A block differs from a recall: it temporarily stops the movement of the batch in the supply chain until a final decision.

What does it mean for destruction and recycling?

This Regulation contains no provision on destruction or waste management. It governs the inspection, sampling and analysis stage that underlies the decision on whether a product stays on the market. If a product is recalled from the market, its return or destruction is dealt with in a separate regulation, Article 16 of the Regulation on the Recall of Human Medicinal Products and Foods for Special Medical Purposes.

The link matters in practice: the fate of a product found unsatisfactory in market control is determined by the return or destruction steps the holder carries out, depending on the class and level of the recall decision.

What should be borne in mind in practice?

For authorisation holders the most critical point is to send specification and analysis information in full within the period set by the Agency; a failure may lead to a block decision through İTS. For active-substance manufacturers the same responsibility rests with the holder of the production-site permit. Market control is not limited to the regular programme: applications reaching the Agency from various sources, or the Agency’s own findings, can also give rise to additional market control activities (Article 6(8)). For the practical details, the Agency may publish explanatory guidelines or communiqués (Article 9).