--- title: "Regulatory Procedures — Regulatory Affairs | QbD Group" description: "There are various procedures available to register pharmaceutical drugs in the EU and UK. The method chosen depends on the type of drug and the intended ro" url: https://qbdgroup.com/en/services/regulatory-affairs/regulatory-procedures type: "Page" language: en publisher: "QbD Group" citation: "QbD Group, \"Regulatory Procedures — Regulatory Affairs | QbD Group\", https://qbdgroup.com/en/services/regulatory-affairs/regulatory-procedures" --- # Regulatory Procedures Navigating EU & UK registration pathways There are various procedures available to register pharmaceutical drugs in the EU and UK. The method chosen depends on the type of drug and the intended route to market. ## Regulatory procedures in the EU & UK There are various procedures available to register pharmaceutical drugs in the EU and UK. The **method chosen depends on the type of drug** (Over the Counter – OTC, prescription drugs – Rx, Generics, new chemical entities, products derived from biotechnology, …) and the intended route to market. **European legislation foresees certain procedures for specific product types**, e.g. the centralized procedure is mandated for products derived from biotechnology, orphan drugs, and drugs designed for certain disease groups such as AIDS, cancer, neurodegenerative disorders, and diabetics. Other products can be registered via the national route or using one of the European procedures, namely the Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP). Our UK-based team can also support you with the UK/GB National Applications and International Recognition Procedure. Last, our experts can also support you in bringing your drugs to the US market. ## How we support you Navigating the regulatory landscape can be complex, but with our expert guidance, you can confidently move forward. We offer tailored support to help you: ### Choose the right procedure We help you select the right registration pathway for your product type and market strategy. ### Advise on a regulatory strategy Strategic regulatory planning aligned with your business objectives and product portfolio. ### Make contact with authorities We establish and manage communication with competent authorities on your behalf. ### Organise and lead meetings We coordinate and lead meetings with regulatory authorities to ensure productive outcomes. ## Procedure types We guide you through each registration pathway available in the EU and UK: ### National Procedure 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. ### Mutual Recognition (MRP) For products to be registered in more than one MS. Based on a national license approved in one EU Member State (Reference Member State – RMS) being mutually recognised in other EU countries (Concerned Member States – CMS). ### Decentralised Procedure (DCP) Follows the same principles of MRP. Used when the product has not yet received a Marketing Authorisation in any MS. The CMSs are involved at the onset of the procedure. ### Centralised Procedure (CP) Application to EMA for a Community Authorization valid across the entire EU. Mandated for biotechnology products, orphan medicinal products, and products for AIDS, cancer, neurodegenerative disorders, and diabetes. ## Line Extensions 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: • Changes to the active substance • Changes to strength, pharmaceutical form, and route of administration • Other changes specific to veterinary medicinal products to be administered to food producing animals ## UK/GB National Applications & International Recognition Procedure (IRP) Applicants can apply for marketing authorization in the UK either by submitting a national application or using the IRP for medicines already authorized by one of the MHRA's specified Reference Regulator countries/regions e.g. EU, US, Japan, Singapore, Switzerland, Canada or Australia. *References: Notice to Applicant Vol 2A Chapters 1, 2, 4; Commission Regulations (EC) No 1085/2003 and No 1084/2003.* Why QbD Group ## Your trusted partner 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. 10+ years of experience: benefit from our team of highly qualified consultants. Full life cycle support: full support from pre- to the post-marketing phase. Global presence: QbD Group operates globally, with a special focus on Europe (EU) and China. Customer satisfaction: constant evaluation, transparency and clear objectives. ## Let's talk Regulatory Affairs From regulatory strategy to product approval, our experts are ready to guide you through every step. Contact us --- Source: https://qbdgroup.com/en/services/regulatory-affairs/regulatory-procedures — © QbD Group. Quote freely with attribution and a link back.