Netherland Drug Product Registration

MOH

Ministry of Health, Welfare and Sports

MOH Website

https://www.government.nl/ 

Regulatory Authority

Medicines Evaluation Board

Regulatory Website 

https://english.cbg-meb.nl/

Local Authorized Representative Required 

Yes

Drug Approval Process

Decentralized Process

When the applicant does not currently hold a marketing authorization in any nation, the decentralized approach should be utilized to get a marketing authorization in multiple Member States. The applicant asks for one nation to serve as the procedure’s Reference Member State (RMS). The first draft evaluation report is provided by the RMS after seventy-one days. Following that, the applicant and the Concerned Member States (CMS) may offer comments. 

The RMS circulates a second draft assessment report on the 120th day of the assessment procedure, based on the company’s responses to the questions submitted by the RMS and other Concerned Member States (CMS). The report includes comments on the SmPC, package leaflet, and labelling texts. In addition, other Member States will typically accept the RMS’s assessment under the Mutual Recognition Procedure during the following ninety days, barring significant objections based on a potentially substantial danger to public health. 

In certain circumstances, additional talks will also take place in the Coordination group for Decentralized Procedures and Mutual Recognition (CMDh). The procedure will be terminated adversely, and no marketing authorization will be given if the RMS still has objections on day 210 that are thought to pose a substantial danger to public health. In this instance, the CMDh does not hold a conversation.

A national marketing authorization is granted upon the mutual recognition and decentralized procedure’s products receiving the approval of all participating Member States. Dutch translations of the SmPC, package leaflet, labeling texts, and mock-ups are then submitted.

Mutual Recognition Procedure

Regarding the Mutual Recognition Procedure (MRP), a marketing authorization has already been obtained by the RMS. Unless they object on the grounds of a potentially serious risk to public health, the other Member States’ requests for mutual recognition of the marketing authorization (including the Summary of Product Characteristics (SmPC), package leaflet, and labelling text) are based on the RMS’s assessment report. More talks in the Coordination group for Mutual recognition and Decentralized processes (CMDh) will take place in such cases.

After the initial MRP is completed, the holder of a marketing authorization may use it many times for the same marketing authorization to have new Member States give them a marketing authorization. The Repeat Use Procedure is the name given to this process (RUP). Preferably, when the national application is submitted, a request to the MEB to serve as Reference Member State in the Mutual Recognition procedure should be made. 

The marketing authorization holder must also get in touch with the relevant case manager or, if known, the Pharmacotherapeutic Group as soon as possible if they want to begin an MRP with a product for which a marketing authorization has already been given. A Repeat Use Procedure is subject to the same rules.

Centralized Procedure

Here, marketing authorizations are granted under the responsibility of the European Commission. The main advantage of this procedure is that new, innovative medicinal products can be made available to all European residents at the same time once marketing authorization has been granted. 

The Centralized procedure also leads to greater efficiency in Europe, as only one or two Member States are asked to produce assessment reports for each medicinal product. Pharmaceutical businesses submit a dossier to the European Medicines Agency (EMA) to participate in the centralized system. The EMA’s medicines assessment committee, the Committee for Medicinal Products for Human Use (CHMP), evaluates the dossier.

In theory, the CHMP has 210 days to make a judgment. The corporation may decide to extend this period so it can respond to inquiries. Additionally, businesses may provide verbal justifications for the dossiers they have filed. The European Commission receives the opinion from the CHMP, which makes the ultimate decision. In most cases, the European Commission takes the CHMP’s position to heart.

The package leaflet and the Summary of Product Characteristics (SmPC) are decided upon after a decision that is deemed favorable. The result is a European Public Assessment Report (EPAR). If the view is negative, details on the reasoning behind the decision are provided. The EMA website contains the EPAR.

A European marketing authorization number is assigned to products that have successfully completed the Centralized procedure to receive marketing authorization. A few goods need to go through the centralized process: biotechnology-made medications and novel medications meant to treat conditions like diabetes, cancer, AIDS, and neurological disorders. Enterprises might choose to register their other new items either nationally or centrally.