Distribute Initials Notification For Free

After approval, the product can be sold but not promoted until price is granted. Italy: L648 regulations allow sales prior to approval and after approval until price is granted. No sales or promotion is permitted apart from under L648 unless reimbursement granted.

Post-authorisation safety study :definition. Any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.

A variation is considered 'unforeseen' when the proposed variation is not considered a minor variation of Type IB following the Commission classification Guideline, or has not been classified as a Type IB variation in an Article 5 recommendation.

Article 61(3) refers to Directive 2001/83/EC in which a so-called ?61(3) Notification? is defined as a change to an aspect of the Labelling and/or Package Leaflet (PL) text not connected with the Summary of Product Characteristics (SmPC).

Parallel distribution is the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing-authorisation holder.

In case of a voluntarily request from the MAH to withdraw a marketing authorisation, the MAH should send a letter to the European Commission to request a withdrawal of the marketing authorisation and provide a copy of the letter to the Product Lead, Product mailbox, Withdrawn product mailbox, Rapporteurs and CHMP Chair

The UK parallel import licensing scheme lets a medicine authorised in European Economic Area ( EEA ) Member State be marketed in the UK, as long as the imported product has no therapeutic difference from the cross-referenced UK product.