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There are various procedures to register pharmaceutical drugs, depending on the type of drug and your intended route to market. QbD Group’s consultants will walk the right path with you.
If an applicant wishes to obtain a license in one Member State (MS) an application must be made to the national Competent Authority (CA) which then issues a national license. Since 1998 national licenses are strictly limited to the initial phase of Mutual Recognition.
Regulation (EC) No 1084/2003 (MRP or DCP) and Regulation (EC) No 1085/2003 (for CP) describe in annex II the types of applications which fall outside the scope of “variations” but at the same time are not complete new applications. Annex II lists three main categories for existing licensed products with:
The Decentralised Procedure (DCP), in general, follows the same principles of the MRP. A licence approved in one Member States (MS) should be mutually recognised in other Member States (MSs) assuming that the evaluation criteria in the EU member states are sufficiently harmonised and are of the same standard. The DCP is to be used if the aim is to obtain marketing authorisation in several Member States (MSs) where, at the time of application, the medicinal product in question has not yet received a Marketing Authorisation in any MS. The main difference between the MRP and DCP lies in the fact that the Concerned Member States (CMSs) in a DCP are involved at the onset of the procedure as opposed to waiting for approval before an application is made in the CMS.
In order to obtain a Community Authorization, an application is made to the EMEA – The European Medicines Agency. The application is scientifically evaluated by the Committee for Medicinal Products for Human Use (CHMP) or the Committee for Medicinal Products for Veterinary Use (CVMP). The European Commission receives an opinion within 210 days and drafts a decision on a Community MA. A MA granted under the CP is valid for the entire EU market.
The Centralised Procedure (CP) is mandated for:
The procedure is optional for other products defined by Council Regulation 726/2004 namely:
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EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS
Choosing QbD Group means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle, ensuring seamless compliance and customer satisfaction on a global scale.
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Have questions about regulatory procedures or need assistance with your pharmaceutical product registration?
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