The requirement for marketing authorization of medicinal products is a cornerstone of pharmaceutical law in the European Union and EU Member States. Triggered by the Contergan (thalidomide) tragedy in the 1960s, strict market surveillance and pre-approval of medicines became mandatory. The European Human Medicines Code, Directive 2001/83/EC, obliges Member States to implement this requirement. For certain medicines, such as oncology drugs, cell and gene therapies, and orphan drugs, EU Regulation (EC) No. 726/2004 mandates centralized authorization at the EU level.

However, there are narrowly defined exceptions to this rule, notably for pharmacy-compounded medicines. Many national laws of Member States exempt “batch-prepared” medicines if they are made in limited quantities in pharmacies based on frequent medical prescriptions. Similarly, patient-specific preparations are often excluded from these requirements if made individually for a patient. These exceptions are also reflected in Article 3 no. 1 and 2 of Directive 2001/83/EC, which excludes formula magistralis and formula officinalis from its scope.

Despite these clear boundaries, practical and legal disputes persist. Some pharmacies attempt to produce on a large scale or systematically, and sell medicines under these exemptions, sometimes competing with authorized products or even manufacturing medicines still under clinical investigation. This creates tension between the principle of premarket authorization and the local law pharmacy exemptions.

However, local laws are heavily influenced by EU law, and the interpretation of national exemptions must consider Directive 2001/83/EC and relevant case law of the European Court of Justice. For medicines requiring centralized authorization under Regulation (EC) No. 726/2004, national exemptions do not apply due to the primacy of EU law. Further, even where a central authorization is not required, local law pharmacy exemptions are to be interpreted as an exception (i.e., in a narrow and strict manner). It has to be considered that only approved products ensure that patient needs are addressed on a well-founded scientific basis and following thorough assessment by regulatory bodies in a rigid approval procedure.

In summary, while pharmacy compounding exemptions exist for patient-specific and batch-prepared medicines, they are strictly limited. The courts emphasize that only non-industrial, pharmacy-typical activities qualify, and any deviation risks undermining patient safety and regulatory oversight. For medicines falling under the mandatory scope of centralized EU authorization, such as advanced therapies and orphan drugs, pharmacy compounding exemptions are not permitted, ensuring rigorous evaluation and protection of public health.

In addition to their patent protection, manufacturers of approved medicines that face competition from compounding pharmacies have a wide array of options to challenge pharmacies that use non-existent exemptions (i.e.,for centrally authorized products), or to try to extend the scope of narrow exemptions.