Important changes to European Union pharmaceutical legislation entered into force on October 30 and 31, 2005. In addition, further amendments will apply as of November 20. The changes include updated rules for the granting of market authorizations for medicinal products, including for traditional herbal medicines, and new, stricter pharmacovigilance (drug safety) rules.
Overview of the New Legislation
EU Member States were required to implement the following Directives into national legislation by October 30, 2005:
- Directive 2004/27/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use;
- Directive 2004/28/EC amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products; and
- Directive 2004/24/EC amending as regards traditional herbal medicines Directive 2001/83/EC on the Community code relating to medicinal products for human use.
Member States were also required to implement the following Directive into national legislation by October 31, 2005:
- Directive 2003/63/EC amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.
In addition, as of November 20, 2005, key parts of the following Regulation will apply throughout the EU:
- Regulation 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, repealing Regulation 2309/93.
Overview of the Substantive Changes
Scope
The new legislation includes a modified definition of ‘medicinal product.’ It also clarifies that when a product falls both within the definition of a medicinal product and the definition of a product covered by other Community legislation (e.g., food, food supplement, medical device or cosmetic product), the rules concerning medicinal products shall apply.
Marketing Authorization Procedures
In the EU, a medicinal product can be granted either a centralized market authorization that is valid throughout the EU, or one or more national market authorizations. Under the new rules, the list of products for which the centralized procedure is mandatory is increased to cover all new active substances for the treatment of AIDS, cancer, diabetes and neurodegenerative diseases. Orphan designated medicines also require a centralized market authorization. The new rules make the centralized market authorization procedure optional for products that contain a new active substance, that constitute a significant innovation, or for which the granting of a centralized market authorization is in the interest of patients.
The legislative changes include altered requirements for the documentation that must accompany an application for a market authorization. For example, an application must contain an evaluation of the potential environmental risks posed by the medicinal product. The situations in which an applicant need not provide the results of pre-clinical tests and clinical trials are also amended. In addition, the reformed legislation contains a new specification of the information that should be included in a summary of product characteristics (‘SPC’).
Moreover, Directive 2004/24/EC establishes a simplified registration procedure for herbal medicinal products.
Pharmacovigilance
The legislative changes coming into force reflect the EU’s efforts to step up pharmacovigilance and, more generally, market surveillance and sanctions in the event of failure to comply with drug safety provisions.
An application for a market authorization must contain a detailed description of the pharmacovigilance and, where appropriate, the risk-management system that an applicant plans to introduce. An application must also be accompanied by proof that the applicant has a qualified person at its disposal and the necessary means for the notification of adverse reactions suspected of occurring either in the EU or in a third country.
Member States are also required to take the necessary measures to ensure that a marketing authorization holder is subject to effective, proportionate and dissuasive penalties.
This article has been prepared by Sidley Austin Brown & Wood LLP for informational purposes only and does not constitute legal advice. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. Readers should not act upon this without seeking professional counsel.