Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Challenges for the SmPC Harmonisation of Generics in Mutual Recognition ***

Nadine Schliecker (Abschlußjahr: 2003)

The Summary of Product Characteristics reflects the essential characteristics of a medicinal product on quality, safety and efficacy, the three fundamental requirements that are evaluated in the European marketing authorisation procedures.

Article 10(1a)(iii) of Directive 2001/83/EC provides an abridged application procedure for generic medicinal products. The quality of the generic dossier undergoes an assessment procedure whereas the information on safety and efficacy refers to the results of pharmacological and toxicological tests and of the clinical trials that are lodged at the authorities disposal for the essentially similar product of the innovator company.

If the European authorities have access to different data concerning the safety and efficacy part of an active substance, the mutual recognition procedure of a corresponding generic will rarely end up with an agreement on a harmonised SmPC. In most cases, Concerned Member State(s) must state "risk to public health" due to a lack of safety and/or efficacy data that justifies the reference according to Article 10(1a)(iii) of Directive 2001/83/EC as reflected in the proposed generic SmPC. In order to avoid a subsequent arbitration procedure that delays the time to market, the applicant often withdraws the applications in the opposing Concerned Member State(s).

With respect to horizontal and vertical harmonisation, the current registration system reverses the SmPC harmonisation process. Consequently, it is currently difficult to realise the European Commission's ideas of a single market, increased transparency and a guaranteed high level of public health.

While the Commission reacts to the progress on disharmonisation by means of Community referral procedures in order to bridge the time that is needed for the review process of the European pharmaceutical legislation, the applicant of a generic product is challenged by the task to create a harmonised SmPC that will be mutually recognised by all Concerned Member State(s).

Although the applicant takes several approaches to reach harmonisation of the SmPC during the national application phase as well as during the mutual recognition procedure, he however, depends on the decision of the authorities in the Member States concerned.

Lastly, all possible activities of the European authorities are bound to the underlying pharmaceutical legislation.

Pages: 53