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Possibility to follow the DCP for a 'duplicate application' of a medicinal product in the MRP

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Question 1
If a duplicate application of a medicinal product authorised via the Mutual Recognition Procedure is submitted via the Decentralised Procedure, will the MS(s) where the application has been submitted be able to accept it?

The CMDh has agreed that a duplicate application of a medicinal product authorised via the Mutual Recognition Procedure can be accepted via the Decentralised Procedure, provided that the same Reference Member State is used.

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Possibility to follow the DCP for an extension application of a medicinal product in the MRP

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Question 2
Is it possible to use the Decentralised Procedure for an extension application of a medicinal product authorised via the Mutual Recognition Procedure?

Yes. The CMDh has agreed that an extension application in accordance with Annex II of Commission Regulation (EC) No. 1084/2003 of a medicinal product authorised via the Mutual Recognition Procedure can be accepted via the Decentralised Procedure.

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Article 17(2) of Directive 2001/83/EC, as amended

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Question 3
Will it be possible for applicants to submit simultaneous applications for marketing authorisation through national procedures in several Member States for the same medicinal product for which an earlier marketing authorisation has not yet been granted in another Member State?

According to Article 17(2) of Directive 2001/83/EC, as amended, where a Member State notes that another marketing authorisation application for the same medicinal product is being examined in another Member State, the Member State concerned shall decline to assess the application and shall advise the applicant that Articles 27 to 39 of Directive 2001/83/EC apply.
As stated in the Notice to Applicants (Chapter 2 of Volume 2A), the Member State which has already started the examination will normally be the future Reference Member State. It is within the responsibility of the Reference Member State either to continue or to restart the procedure after receiving the information that in other MS an application for the same medicinal product by the same applicant is pending.

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Article 18 of Directive 2001/83/EC, as amended

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Question 4 (Last update: April 2009)
If an application for a marketing authorisation  is submitted nationally or via the Decentralised Procedure in a MS and that MS is informed that the same medicinal product¹ has received a marketing authorisation in another MS, will the MS where the application has been submitted be able to accept it?

According to Article 18 of Directive 2001/83/EC, as amended, where a MS is informed that another MS has authorised a medicinal product which is the subject of a marketing authorisation application, the MS concerned will reject the application unless it was submitted under the Mutual Recognition Procedure and will inform the MS where the product has been authorised.

As stated under 3.2, chapter 2 of volume 2A of Notice to Applicants, differences between the SPC, package leaflet and labelling approved in one Member State and the SPC, package leaflet and labelling submitted in another Member State do not automatically prevent the latter from a Mutual Recognition Procedure. If these differences have no therapeutic implications (no difference in the efficacy and safety profile), i.e. both products have the same qualitative and quantitative composition in active substances (i.e. the same strength) and the same pharmaceutical form, they have to be considered as being the same and the MRP has to be followed.
Independent national procedures can be used for extensions of authorised medicinal products as far as no a priori harmonisation has been achieved for the initial marketing authorisation.

Different dossiers for a product with the same qualitative and quantitative composition in active substances, the same pharmaceutical form and same MAH

• Different dossiers for the same medicinal product from the same MAH are not recommended and considered not to be in accordance with the principles of the single market. However, if these dossiers exist for historical reasons or due to a merger, it is not possible to coexist in the same marketing authorisation procedure, because Article 28(1) of Directive 2001/83/EC, as amended states in this regard that "with a view to the granting of a marketing authorisation in more than one Member Stae, an applicant shall submit an application based on an identical dossier in these Member States";

CMDh recommends the following for handling these applications:

• Applicants should comply with Article 8(3)(1) and provide copies of any authorisation obtained for that medicinal product with the application for marketing authorisation. This should allow the Competent Authorities to verify that the provisions of Directive 2001/83/EC, as amended are being complied with;
• The acceptance of an application for marketing authorisation for a different dossier should not lead to applications for the same product being submitted in different Member States and handled outside the principles of Mutual Recognition laid down in Chapter IV of Directive 2001/83/EC, as amended;
• The same Reference Member State should be used, where possible, also in the situation where the dossiers differ, in accordance with the CMDh recommendations on multiple/duplicate applications in MRP and DCP; if the same Reference Member State cannot be used, the CMDh recommends the use of one of the Concerned Member States involved in the previous procedure as the Reference Member State;
• Applicants can decide whether to use the Mutual Recognition Procedure or the Decentralised Procedure for the "duplicate" marketing authorisation.

1 Same medicinal product means same qualitative and quantitative composition in active substance(s) and having the same pharmaceutical form from applicants belonging to the same mother company or group of companies OR which are "licensees"

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Information on fees payable to Member States in the MRP/DCP

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Question 5
Which is the best way to get information on the fees payable to every MS when they act as RMS or CMS in the Mutual Recognition or Decentralised Procedure?

This information is provided by national competent authorities. Addresses for receipt of fees and details of how payments are to be made are set out in Chapter 7 of the Notice to Applicants.

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Communication

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Question 6
How should the communication in a MRP/DCP be directed?

Applicants are reminded that the Reference Member State (RMS) is the main contact point during a MRP/DCP. In case of any direct communication between Concerned Member States and local affiliates of the Applicant, the RMS should be kept informed.

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General information on national requirements

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Question 7
Where can I find general information regarding national requirements for MRP/DCP?

Further to the work carried out by the Working Group on Validation Issues/National Requirements in the framework of the Mutual Recognition and Decentralised Procedures, the CMDh has published on the website the Additional data requested for new applications in MRP/DCP.
This information is also available in Chapter 7 of Volume 2A of the Notice to Applicants.

The Notice to Applicants is published in the European Commission website: http://ec.europa.eu/health/documents/eudralex/vol-2/index_en.htm.

For information on the presentation and content of the dossier or on regulatory Guidelines, please consult Volume 2B or 2C of the Notice to Applicants, respectively.

 

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Bibliographical applications and mutual recognition/national procedure

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Question 8
The Decentralised or Mutual Recognition Procedures are compulsory when the same Applicant intends to market a medicinal product in more than one Member State.
Can you clarify when two or more Companies are considered to be the same Applicant?

According to the Commission communication on the Community marketing authorisation procedures for medicinal products 98/C 229/03, two or more companies are considered to be the same applicant when they belong to the same mother company or group of companies or when, without belonging to the same mother company or group of companies, have concluded agreements (e.g. ‘licensees’) or exercise concerted practices concerning the placing on the market of the relevant medicinal product in different Member States.

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Question 9
When a Company has sold a dossier for a medicinal product to an unrelated Company, is it possible for both Companies to apply nationally for Marketing Authorisation in different Member States?

Yes, they should both apply nationally in any Member State (the same or different) and afterwards initiate a mutual recognition procedure if they intend to market the medicinal product in more than one Member State, unless they can be considered to be the same applicant (as defined in Question 78). It is not possible to start a mutual recognition procedure based on a marketing authorisation granted for a different applicant, even though the content of the dossier is the same.

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Question 10
Is it optional for a Company to submit a bibliographic application when there is an original/reference medicinal product to which essential similarity can be claimed, or is an application, in accordance with Article 10(1) or 10(3), the appropriate legal basis for such an application?

According to Chapter 1 of Volume 2A of NtA, bibliographic applications may be submitted for any medicinal product (chemical or biological substance) if it can be demonstrated that the active substances of a medicinal product have been in well established medicinal use within the Community for at least 10 years, with recognised efficacy and an acceptable level of safety.

The CMDh recommends that applications in accordance with Article 10(a), Directive 2001/83/EC, as amended (bibliographical applications) be only submitted when there is no reference/medicinal product to which essential similarity can be claimed.

As for other applications, the MRP or DCP is compulsory for bibliographical applications intended for authorisation in more than one MS (where the centralised procedure is neither mandatory nor chosen by the Applicant).

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Combination Packages

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Question 11
What is the definition of a Combination Package? Is it possible to apply for Combination Packages through MRP or DCP?

There is no definition of a combination package in Directive 2001/83/EC, as amended, but the CMDh has agreed on the following understanding of a combination package:
A combination package is a package, which contains more than one medicinal product marketed under a single tradename, and intended to be used in a medical treatment where the individual medicinal products are simultaneously or sequentially administered.
The combination packages should be distinguished from a fixed combination which is a combination of active substances within a single pharmaceutical form.

The medical tradition of using combination packages is different among the EEA Member States. However, most of the Member States have accepted combination packages for some medicinal products including vaccines and some HRT products. If a combination package is accepted, it is considered as a unique product with its own marketing authorisation and the holder of the marketing authorisation has the full legal responsibility for the product. In principle, many Member States could accept a combination package if there are strong arguments for the provision of a combination package with respect to benefit to public health or where the use of a combination package is more user friendly for the patient or healthcare professional. Commercial reasons are not considered a valid justification for the provision of a combination package. Due to the different medical traditions among Member States, CMDh advice to applicants is to consult with the RMS well in advance of any future MR or DC procedure in order to clarify the acceptance of the combination package in the relevant MSs.

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Manufacturing sites restricted to particular Member States in the MRP and DCP

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Question 12
Is it possible in a MRP/DCP to register a manufacturing site or batch release site for a limited number of Member States (i.e. not all MSs included in the procedure)?

Manufacturing sites and batch release sites approved via the MRP/DCP are considered approved for all MSs included in the procedure. Even though not all manufacturing sites are necessarily intended for use in all MSs included in the procedure, it is not necessary to specify in the application form which site applies to which MS.
 
It is not possible to delete manufacturing sites for medicinal products authorised via the MRP/DCP on a national basis. The MRP variation procedure should be followed, as all manufacturing sites for a MRP/DCP apply to all MSs involved in the procedure.
 
With regard to the identification in the package leaflet (PL) of the manufacturer responsible for batch release in the EEA, the locally printed PL in each MS needs only to include the manufacturing site specific to that MS. The change of this information only in the PL approved by a MS will be managed at the national level.

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Change in the name of a medicinal product prior to granting a Marketing Authorisation

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Question 13
How should a change in the name of a medicinal product between finalisation of a MRP or DCP and prior to granting a national marketing authorisation, be handled?

It should be discussed with the particular Member State whether or not the change in the name of the medicinal product can be handled as part of the national implementation process. If this is the case, then MAHs are reminded that the mutually recognised English Package Leaflet should be updated e.g. Article 61(3) procedure. If the change in the name of the medicinal product can not be handled as part of the national implementation process, then a MRP variation should be submitted.

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Numbering of follow-up submissions and commitments

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Question 14
Which MRP-DCP number should be assigned to follow-up submissions and commitments?

Follow-up submissions and commitments should be numbered according to the following number CC/D/nnnn/sss/FU/vvv, in which the element

• CC is the initial of the Reference Member State (two letter code)
• D is 'H' for medicinal products for human use
• nnnn is the 'Medicinal Product Number' characterisind the medicinal product
• sss is the 'Speciality Number' characterising the strength and/or pharmaceutical form of a medicinal product
• vvvv is the chronological number

Principles:
Irrespective of the type of submission (follow-up submission or commitment) there is a continuous number of the submitted follow-up submission and commitments.

Basis for the continuous numbering is the medicinal product characterised by 'Medicinal Product Number'.
Only identical follow-up submissions/commitments are entitled to have the same chronological number.
Follow-up submissions/commitments have their own series of sequential numbers and are separate to other procedures.

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