The decentralised procedure - questions and answers
How should you contact the Danish Health and Medicines Authority if you as an applicant wish to use Denmark as the reference member state?
You should contact the Danish Health and Medicines Authority 2 to 3 months before you submit the application stating the name of the active substance and the proposed date of submission. The Danish Health amd Medicines Authority will then contact you.
Should the Danish Health and Medicines Authority be contacted earlier if Denmark is concerned member state?
It is not necessary to contact the Danish Health and Medicines Authority earlier as the reference member state is the contact point for the applicant.
Is it possible for the Danish Health and Medicines Authority to pre-evaluate the dossier before the application is submitted?
The Danish Health and Medicines Authority may assist by answering questions about some parts of the application as well as procedural questions; however, we cannot evaluate the entire dossier until the application is submitted.
When is a procedural number allocated?
As soon as it has been agreed that Denmark is the reference member state, the procedural number can be allocated. The allocation can take place from one day to the next.
Who should be informed when a European reference product is used – and how?
It is important to inform the reference member state, as the reference member state (RMS) needs information on the reference product for the assessment report.
An application is not valid until the reference member state has received this information.
What does the fee cover in Denmark when the Danish Health and Medicines Authority acts as the reference member state?
The fee covers all pharmaceutical forms, strengths and indications comprised by the procedure and according to Executive Order no. 1240 of 12 December 2005.
Should the application include summary of product characteristics, package leaflet and labelling in Danish?
It is sufficient that the product information is in English at the time of application. Mock-ups should be available in one EEA language.
Could the package leaflet be omitted in applications for preparations administered by health-care professionals?
No, for all medicinal products the application must include a draft package leaflet, cf. Article 58 of Directive 2001/83/EC as amended.
Should the substance name be stated in Braille if you apply for a medicinal product with an invented name?
No, this is not required by legislation. The Danish Health and Medicines Authority follows the Commission’s “Guidance concerning the Braille requirements for labelling and the package leaflet”.
Where should the ”blue box” appear in the package leaflet?
The blue box is a fictitious concept. The national requirements are stated under the main headings of the package leaflet where the required standard phrases belong.
What are the national ”blue box” requirements of the Danish Health and Medicines Authority?
The national requirements are published in Notice to Applicants, Volumes 2A and 6A, Chapter 7.
Does the Danish Health and Medicines Authority allow ”user consultation”/test to be carried out in other languages than Danish?
Yes, the cooperation with patient target groups does not need to take place in Denmark. However, the result of the cooperation with patient target groups must be in English.
When should changes to labelling and package leaflets be implemented for MRP products?
The changes must be implemented before 1 January 2009 when the medicinal product is distributed to the wholesaler for products authorised no later than 29 October 2005 unless an earlier date has been agreed.
Are the proposals for summary of product characteristics, package leaflet and labelling subject to any specific format requirements?
You should use the QRD templates when you submit proposals. This is based on an agreement between the member states on use of common standard . The templates can be found on the EMEA’s website.
Should all names appear on the package leaflet if a medicinal product submitted through the decentralised or the mutual recognition procedure is approved under different names or a national approved medicinal product with different names is subject to a referral?
Yes, this is a requirement according to Article 59, paragraph 1 (g) of Directive 2001/83/EC (human) and Article 61, paragraph 2 (b) of Directive 2001/82/EC (veterinary).
Can the decentralised procedure be finalised before 210 days have elapsed?
It is possible to complete earlier if there is agreement on the assessment report, the summary of product characteristics, the package leaflet and labelling on for instance day 120 or day 150.
Is there any risk of a negative assessment during the application procedure by the reference member state?
There is always a risk that the reference member state will assess the application negatively.
For that reason we recommend a ”robust” dossier.
Can the reference member state be changed during the procedure?
It is not possible to change the reference member state during the procedure.
Can the application be withdrawn without the application being referred to the CMD?
In principle, an application can be withdrawn throughout the procedure. From step II (day 120) any by day 210 unsolved grounds of ”potential serious risk to public health” will be referred to the CMD.
Which types of application may be referred to the CMD?
The following applications may be referred to the CMD:
- New applications
- Repeat use applications
- Extensions and renewals
- Variations are not covered by legislation.
Can a marketing authorisation be granted while the CMD is reviewing an application?
No, no marketing authorisation will be granted during the review by the CMD in the involved member states.
How will the referral procedure be in the CMD?
The member states must do their utmost to reach agreement. At the moment, the CMD is preparing guidelines for “Questions and Answers” about referrals.
Will the Danish Health and Medicines Authority prepare a Danish version of the Public assessment report and publish it on its website?
The report is prepared in English by the reference member state and will be published on the website of Heads of Agencies. The Danish Health and Medicines Authority does not plan to prepare a Danish version.
Has the Danish Health and Medicines Authority any experience with the procedure?
The Danish Health and Medicines Authority only begins to act as a reference member state as from January 2006.