Pharmacy compounding under the EU pharma law package

Medicinal products prepared industrially or via an industrial process

Medicinal products that are prepared industrially or that are manufactured by a method involving an industrial process must comply with the Medicinal Products Directive. This includes the requirement that a medicinal product may only be placed on the market in the EU after a marketing authorisation has been issued for the product. It also includes the requirement that manufacturing of medicinal products must be done by manufacturers that hold a manufacturing authorisation and that comply with principles of Good Manufacturing Practice (GMP). The concepts ‘prepared industrially' and ‘manufactured by a method involving an industrial process' are not defined in the Medicinal Products Directive. The CJEU has clarified that the standardised production of significant quantities of a medicinal product to be stocked and sold wholesale is a characteristic of ‘industrial preparation' or ‘manufacture by a method involving an industrial process'. Interestingly, in the Commission's proposal and the Parliament's position, this explicit description of the scope is no longer to be found. The explanatory memorandum accompanying the EU Pharma Law Package however makes clear that the overall scope of the Medicinal Products Directive will not be changed.

‘Magistral formula' and ‘officinal formula'

‘Magistral formula' and ‘officinal formula' preparations are excluded from the scope of the Medicinal Products Directive. ‘Magistral formula' preparations involve medicinal products that are prepared in pharmacies in accordance with medical prescriptions for individual patients. ‘Officinal formula' preparations refer to medicinal products that are prepared in a pharmacies (i) in accordance with the prescriptions of a pharmacopoeia and that (ii) are intended to be supplied directly to the patients served by the pharmacies in question. Unlike ‘magistral formula' preparations, ‘officinal formulas' preparations are not customised for individual patients. The exceptions of ‘magistral formula' and ‘officinal formula' preparations are retained in both the Commission's proposal and in the position of the Council. The Council has nevertheless adopted a broader definition of ‘magistral formula' preparations: it also refers to medicinal products available without medical prescription with an instruction of a doctor or another healthcare professional where provided for in national law for an individual patient.

The interpretation of ‘officinal formula' preparations, or “stock preparations”, are the subject of a preliminary questions procedure at the CJEU initiated by the Dutch Supreme Court. The Netherlands knows a tolerance policy in relation to stock preparations. This policy from the Dutch Healthcare Inspectorate allows pharmacies to prepare a certain quantity of a medicinal product without the need for a marketing authorisation for the medicinal product in question and without the need for a manufacturing authorisation. One of the preliminary questions the CJEU is asked to answer is whether national authorities are free to subject medicinal products that fall under ‘officinal formula' exemption (whereby the marketing authorisation requirement does not apply) to a national authorization requirement based on a quantitative condition (a numerical criterion).

Under the Pharma Law Package, pharmacies would be allowed to prepare stock of ‘magistral formula' medicinal products in advance, on the basis of the estimated medical prescription. While the Commission proposal limits this to stock preparations by a pharmacy serving a hospital, the Council proposes to broaden this to any pharmacy preparations. The Council proposes to allow such stock preparations for a period of up to four weeks.

Conclusion and next steps

In the EU Pharma Law Package the provisions regarding pharmacy compounding are subject to several changes. Most changes are rather a clarification of the existing legal framework. One of the things that is perhaps most uncertain at this point is whether ‘magistral formula' preparations prepared in advance may be supplied by pharmacies serving hospitals or by any pharmacy.

Now that the Council has taken its position, negotiations can take place between the Council and the European Parliament. It is generally not expected that the new legislation will go into effect until 2028, considering the transition periods of 18 months (as the Commission and Parliament propose) or even 36 months (as the Council proposes) after the entry into force of the legislation. It is likely that by then the CJEU will already have provided its judgement on the interpretation of the ‘officinal preparation' exemption under the current legal framework. 

This article is part of a series that discusses amendments to the EU Pharma Law Package and highlights the different positions adopted by the Commission, Parliament and the Council compared to the current pharmaceutical regulatory framework. Please contact the authors or the Hogan Lovells attorneys with whom you regularly work for guidance on your specific product needs.

Authored by Hein van den Bos and Samantha van Dijk.