The EU Medicinal Products Directive in the Balkans: are candidate countries aligned with its key provisions?

This is clearly important for Europe, as it affects coherence, stability and the overall progress of EU integration efforts. In the coming period, the assessment is expected to take place, along with further national-level legislative reforms in the same direction.

The assessment is intended to assist candidate countries in adopting national legislation aimed at achieving full alignment with the EU acquis, including in the area of public health. 

This article provides an overview of the compliance of five candidate countries – Albania, Bosnia and Herzegovina, Montenegro, North Macedonia and Serbia – with EU public health legislation, in particular with certain key provisions of the EU Medicinal Products Directive.[1]

What is the EU Medicinal Products Directive?

The EU Medicinal Products Directive regulates medicinal products for human use in the EU, covering those that are industrially produced or manufactured via industrial processes. It is a cornerstone of EU health legislation, providing a comprehensive legal framework for medicinal products to ensure their safe production, distribution and use, thereby safeguarding public health across the Union.

National provisions – overly broad scope of application

The national laws of these countries (generally referred to as the Law on Medicines) provide for a broader scope of application than the Directive. 

Specifically, in addition to medicinal products for human use (to which the Directive applies), the national laws also cover other categories, such as veterinary medicines in Montenegro and Serbia, and medical aids in North Macedonia.

The exception is Albania, where the scope of application of the national law on medicines aligns with that of the Directive. 

Non-conformity and incompleteness regarding the definitions of the exceptions

In North Macedonia and Serbia, there are provisions that largely mirror the wording of Article 3 of the Directive, which lists cases where the Directive does not apply. However, their context is different: instead of stipulating the categories to which the national laws do not apply, these provisions refer to categories of medicines for which a licence is not issued. 

An exception is the Montenegrin law on medicines, which reflects both the wording and the application context of Article 3 of the Directive, although with somewhat broader scope and minor language differences. 

In contrast, in Bosnia and Herzegovina, state- and entity-level legislation do not include any provisions on non-applicability.

This illustrates both non-conformity (whether national provisions are substantively aligned with EU norms) and incompleteness (whether all relevant provisions are addressed in national law). Therefore, the practical implications of these provisions may vary significantly across jurisdictions.

Distribution of unauthorised medicinal products

The EU Medicinal Products Directive permits a Member State to temporarily authorise the distribution of an unauthorised medicinal product in response to the suspected or confirmed spread of pathogenic agents, toxins, chemical substances or nuclear radiation, any of which could pose a risk to health.

In Albania, the national law regulates the matter of issuing a conditional marketing authorisation (rather than temporary authorisation). In Bosnia and Herzegovina, the relevant laws and bylaws regulate the urgent import of unlicensed medicines, but not in the fully harmonised manner stipulated by the Directive.

Montenegrin law aligns with the Directive in exempting manufacturers, health professionals and marketing authorisation holders from liability when medicinal products are used without authorisation under the instruction of competent authorities in response to public health emergencies. 

The relevant laws of North Macedonia and Serbia address this topic in a very similar manner, although the national provisions differ in formulation from the EU norm and are applied under different circumstances. North Macedonia, nevertheless, serves as a positive example of proactiveness in aligning with the EU legal framework, as a new Law on Medicines is being drafted with the aim of full alignment with the Directive.

Towards EU harmonisation

There is only limited compliance and conformity with the EU Medicinal Products Directive in terms of considered national provisions.

In this context, EU initiatives play an important role by assessing the level of regulatory development of non-EU countries and providing targeted support to further align national legal frameworks with the EU acquis.

Finally, to achieve more effective and comprehensive compliance with EU standards, harmonisation efforts at the national level in candidate countries need to be further intensified. Additionally, well-balanced and improved inter-institutional cooperation can foster a constructive approach to the alignment process. No less important is the engagement of relevant stakeholders, which can help ensure the process is transparent, inclusive and adapted to local needs.

authors: Srdjana Petronijevic and Marija Vranic