Referral procedure
- Published: January 29, 2021
- Last updated: January 27, 2022
Referrals are a collection of different procedures used when EU Member States have not reached agreement on decisions concerning medicinal products. A referral procedure can be initiated on the initiative of a Member State, the European Commission or a Marketing Authorisation Holder (MAH).
The referral procedure may concern one of the following:
- a particular product which has been approved through one of the four authorisation procedures
- a specific substance
- product class.
Procedures are usually referred either to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) or to the European Medicines Agency’s Committee for Medicinal Products for Veterinary Use (CVMP).
The committees are tasked with carrying out the scientific assessment for all the Member States concerned.
Procedures concerning safety of a medicinal product
However, procedures concerning the safety of medicinal products for human use are handled by the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). As regards safety procedures involving at least one product approved by the centralised procedure, the final decision is taken by the European Commission on the basis of PRAC’s recommendation and CHMP’s opinion.
When no product authorised via the central procedure is included, it is the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) which must express a position (CMDh position) by consensus or by majority. The position must also be based on PRAC’s recommendation.
If the position is reached by consensus, it will apply as a final decision. If the position is reached by majority, the European Commission will take the final decision.
In other referral procedures, the final decision is taken by the European Commission based on the opinion of CHMP or CVMP. The opinion may be re-examined by PRAC/CHMP/CVMP.
Different types of referral procedures
| Safety, quality, manufacturing and effect | |
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Article 20 (EC) No 726/2004 |
Medicinal products approved by the centralised procedure, when subject to a referral procedure relating to the manufacture and safety of medicinal products. |
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Article 31 2001/83/EC |
The procedure concerns interests common to the European union regarding the quality, safety or efficacy of medicinal products. |
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Article 107i 2001/83/EC |
Procedures: - where consideration is being given to suspending or revoking a marketing authorisation - where consideration is being given to prohibiting the supply of a medicinal product or refusing a renewal application - where the MAH has interrupt the placing on the market of a medicinal product or taken steps to withdraw an authorisation, and - where a new contraindication, reduction in the recommended dose or restriction of indications is necessary. This procedure is initiated by a Member State or the European Commission if urgent action is deemed necessary. |
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Paediatric medicines |
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Article 29 (EC) No 1901/2006 |
In the case of applications for a new indication, new pharmaceutical form or new drug administration route for use in children for products authorised under EU Directive 2001/83/EC. If necessary, the marketing authorisation holder initiates the procedure. |
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Medicinal products for humans authorised by the mutual recognition procedure (MRP) and the decentralised procedure (DCP) |
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Article 13 (EC) No 1234/2008 |
When there is disagreement between Member States concerning a current procedure relating to a type II variation. |
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Article 29(4) 2001/83/EC |
For decisions in the MRP when there is disagreement between Member States concerning potentially serious risks to public health in current procedures such as renewal and new applications. |
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Article 30 2001/83/EC |
When Member States have reached different authorisation decisions for a medicinal product for which harmonised summaries of product characteristics should be prepared. For example, different indications and contraindications. |
Decisions following referral procedures
The Swedish Medical Products Agency (Swedish MPA) must reach a decision in accordance with a unanimous position in referral procedures or the decision that follows from the European Commission’s decision in cases where no agreement can be reached.
The MAH must:
- submit the variation applications that are necessary to enable the Swedish MPA to reach the decision that follows from the decision in the referral procedure
- at an early stage after the decision of a referral procedure, contact the Swedish MPA if there are any doubts as to the action to be taken by the MAH.
National products in the mutual recognition procedure (MRP)
When national products are in the mutual recognition procedure (MRP), the authorisation may have to be adjusted with regard to the Asp and MA numbers in order to maintain harmonisation of the product information.
Contact the Swedish MPA regarding any questions relating to existing Asp numbers for national products and the registration of new products for the MRP.
Email: RIC@lakemedelsverket.se
Product information
- The most recently approved version of the product information must be updated in accordance with the texts established through a Commission Decision.
- The product information must be attached in Word format to the relevant variation application.
- Changes to the text must be displayed using the ‘Track Changes’ function in Word.
- Swedish product information is enclosed for the national procedure.
- For the DCP, English (common) and Swedish versions of the product
- However, if the product is not to be launched on the market in Sweden, this is notified instead of enclosing Swedish product information.
Labelling model (Mock-ups)
Electronic applications must include mock-ups as attachments in PDF format, preferably version 1.7 or alternatively version 1.4, to enable electronic storage.
If the outcome of the referral procedure affects the name, strength, pharmaceutical form and/or animal species for products which are already on the market, new packaging may have to be placed on the market from the date on which the variation application is approved. In such a case, this must be communicated in the cover letter for the variation application as the date of authorisation may need to be adjusted.