Belgium - Federal Chamber of Representatives Approves New Law governing Raw Materials Used by Pharmacists
- 26/02/2024
- News
On 22 February 2024, the federal Chamber of Representatives approved in plenary session bill 55K3786 regarding the raw materials used by pharmacists (Wetsontwerp betreffende de grondstoffen gebruikt door de apothekers/Projet de loi relatif aux matières premières utilisées par les pharmaciens - see, attachment – the Law; the text approved in plenary session is identical to the version which the Committee for Health and Equal Opportunities approved on 16 February 2024).
The Law will replace the Royal Decree of 19 December 1997 regarding the control and analysis of raw materials used by community pharmacists. However, it will not enter into force until a date to be determined by a new Royal Decree at the latest on the first day of the 25th month following the month of its publication in the Belgian Official Journal.
The Law is designed to regulate the raw materials that serve as the basis for both magistral and officinal preparations for both human and veterinary use in both community and hospital pharmacies. Such preparations fall outside the scope of the current and future EU rules governing medicines for human use (see, Articles 3(1) and 3(2) of Directive 2001/83/EC on the Community Code relating to medicinal products for human use and Article 1(5) of the proposed Directive on the Union code relating to medicinal products for human use) and are only partly covered by the EU rules governing veterinary medicinal products (see, Article 2(6)(b) and (c) of Regulation 2019/6 on veterinary medicinal products).
Under the central tenet of the Law, all raw materials commercialised in Belgium will be required to have a licence which implies that such raw materials should be described in an analytical reference. Article 11, §1 of the Law establishes a hierarchy of analytical references listing 4 “cascading” tiers including (i) the European pharmacopeia; (ii) the Belgian pharmacopeia or another official pharmacopeia that reflects the state of the scientific and technical knowledge; (iii) the “Deutscher Arzneimittel-Codex”; and (iv) a monography approved by the competent Minister.
The Law provides for an exception to this basic principle of licenced raw materials for raw materials which are essential to a very small group of patients afflicted by a rare or chronic disease and for which there are no alternative raw materials or medicines available. The Federal Agency for Medicines and Health Products (FAMHP) will have the power to confer on such products the status of raw materials for limited use.
The Law also creates a licensing system for producers and distributors of raw materials and furthermore establishes rules that apply to parties based abroad and to imports from both EU Member States and third countries.
While the Law creates a new regulatory framework, it still leaves a lot to be regulated by Royal Decree. The long waiting period of possibly more than two years before the Law will enter into force is explained by the plan to have the Law and the implementing Royal Decree become operational simultaneously. The waiting period was a point of concern expressed during the parliamentary discussions, along with the question how the FAMHP will cope with its added responsibilities when it is already having trouble dealing with its current tasks. For example, the average time to obtain a monography is at present reportedly 3 years.
