Regulation on the Recall of Human Medicinal Products and Foods for Special Medical Purposes

The Regulation on the Recall of Human Medicinal Products and Foods for Special Medical Purposes, published in Official Gazette No. 32701 of 23 October 2024, sets the rules, powers and responsibilities for investigating products that are suspected of being defective, found defective or considered unsafe to use, and, where necessary, for withdrawing them from the market quickly and effectively in the interest of consumer health and safety (Article 1). It is based on Law No. 1262 on Pharmaceutical and Medicinal Preparations (Article 3) and repealed the Recall Regulation published in Official Gazette No. 29537 of 19 November 2015 (Article 20).

Which products does the Regulation cover and what does “recall” mean?

The Regulation covers human medicinal products licensed or authorised by the Turkish Medicines and Medical Devices Agency (the Agency), the active substances used in making them, and foods for special medical purposes (Article 2). A recall (geri çekme) means the collection of a defective or suspected defective product from specific distribution chains by the marketing authorisation holder, according to the recall level (Article 4). “Blocking” means temporarily stopping the movement of a product batch in the supply chain until a final decision is made; it is carried out through the Pharmaceutical Track and Trace System (İTS).

What are the recall classes, levels and deadlines?

The class is determined by the risk of harm to consumer health and the nature of the defect (Article 9). The level shows how far down the distribution chain the recall reaches (Article 10). After the announcement, the authorisation holder must take measures to bring the defective product under control within a period that depends on the class (Article 13).

• Class I: cases where there are acceptable grounds to believe serious and life-threatening health problems have occurred or may occur; control within 24 hours. The Agency announces these recalls on its official website.
• Class II: cases where temporary and treatable health problems have occurred or are likely; 48 hours.
• Class III: cases where using the product is not harmful to health; 72 hours.
• Level A covers all users and recipients who can be contacted, Level B all places supplying the end user, and Level C pharmaceutical wholesalers.

How does the recall process work?

Notifications may be made to the authorisation holder, to the provincial health directorate or directly to the Agency (Article 7). Within the Agency, a seven-member Recall Evaluation Commission may request further information from the holder, block the batches concerned through İTS, take samples for analysis, start a good manufacturing practice inspection at the production site and decide the class and level of the recall (Article 8). If the Agency initiates the recall, it asks the holder to return the Annex-1 form within five working days at the latest (Article 11).

The announcement must be in writing, follow the text in Annex 2, contain no advertising and be copied to the Agency (Article 12). The holder submits a preliminary report within ten working days of the decision (Article 14) and, once sure that all defective products in scope have been recalled, a final report within twelve weeks at the latest; a one-off four-week extension may be granted (Article 17). Distribution records and recall documents are kept for at least five years after the expiry of the product’s shelf life (Article 6).

What does it mean for destruction and waste?

Destruction is one of the final steps of a recall. After the provincial or district health directorate carries out its determination procedures, the authorisation holder either returns the product to its source or destroys it in a manner appropriate to its nature, in line with the relevant legislation (Article 16). The holder must determine the quantity of recalled product and carry out destruction or return (Article 6(1)(i)). A product that can be rectified may be placed on the market again by Agency decision after checks and, if needed, analysis.

The Regulation does not itself lay down the technical method of destruction; it refers to “the relevant legislation”, and depending on the product, waste management rules may also come into play. The final report must show that destruction was carried out in accordance with that legislation or that the product was returned (Article 17(2)). Remedying the hardship of those affected by recalled products is also the holder’s duty (Article 15).

What sanctions apply in case of non-compliance?

Articles 18 and 20 of Law No. 1262 apply to the authorisation holder for the non-conformity found; in class II and III recalls started by the holder, the voluntary nature of the recall is taken into account in deciding on penalties (Article 18(1)). Those who continue selling the defective batch after the recall announcement or fail to implement the recall decision are subject, depending on the act, to Law No. 1262, Law No. 7223, the Turkish Penal Code and the Law on Misdemeanours (Article 18(2)). Distributors, on receiving the announcement, must also prevent use of the batch concerned and issue a feedback record (Article 6(2)).