Principles and procedures for a ‘switch’ of the legal status of a medicinal product from prescription to non-prescription – Romania

Principles and procedures:

• It is to the applicant to claim the one-year data exclusivity at the time of the application for the change of classification. The submission can be both within or separate from an existing marketing authorization.

• The applicant shall support its claim by providing a report justifying that its application includes significant preclinical tests or clinical trials which have been carried out in relation to this change of classification in accordance with Article 74a of Directive 2001/83/CE and this Guideline provisions.

• Such documentation should be submitted in Module 1 of the application for a variation or extension application to an existing marketing authorization or for a standalone for marketing authorization.

• Related study reports and literature references shall be placed in relevant Modules of the dossier and thus cross-referred accordingly.
 

Aspects related to national/mutual recognition/decentralised procedure only

• It is expected that data exclusivity would be applied by each competent authority, irrespective of whether the data was common to more than one application.

• For marketing authorizations processed through the mutual recognition or decentralized procedures each competent authority will take its own decision as to whether the one-year data exclusivity period is to be granted.

• Nevertheless, in the view of harmonizing medicinal products throughout the Community and to keep the already reached harmonization in a mutual recognition or decentralized procedure it is recommended to the competent authorities of the Member States to use their best endeavors to reach an agreement on the legal status of a medicinal product and on the one-year data exclusivity.

• The decision of each competent authority authorizing the change will contain a clear statement of whether the change in classification is based on significant pre-clinical tests or clinical trials.
 

Aspects related to centralized procedure only

• Where the change in classification is submitted within an existing Marketing authorization, the change requires the submission of a Type II variation application, unless it introduces the need for an extension application e.g., a new strength, pharmaceutical form, route of administration, or any other. Alternatively, a separate standalone application for marketing authorization could be submitted.

• The CHMP will assess the pre-clinical or clinical trials and issue a single opinion for the change of the classification. A Commission Decision will authorize the change in classification including a clear statement of whether the change in classification is based on significant pre-clinical tests or clinical trials.

7.4 Name of the Medicinal Product

It is to the applicant in the case of a switch from ‘prescription’ to ‘non-prescription’ status of an already authorized medicinal product to choose whether to retain the same invented name or to choose a new invented name.