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Languages to be used for applications for marketing authorisation in the Decentralised or Mutual Recognition Procedure

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Question 1
Is it possible to submit text proposals for the SPC, Package Leaflet and Labelling for applications for marketing authorisation via the Mutual Recognition or the Decentralised Procedure in English only?

Yes. Member States have agreed to accept text proposals for the SPC, PL and labelling in English with the submission of the application. However, sample mock-ups in an official language of the EU should also be submitted for the application to be considered valid.
It will not be essential to undertake user testing on leaflets drawn up in more than one language and the testing may be done on leaflets prepared in any official language of the EU which may not necessarily be the language of the RMS. Results of such tests should be presented in English to permit the assessment of the test to be undertaken by RMS and CMS as necessary.
High quality translations of the agreed SPC, PL and labelling should be submitted at the latest 5 days after the end of the procedure; however, these may be required earlier in the procedure by some Competent Authorities.

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Languages to be used for applications for variations and renewals to marketing authorisations granted via the Decentralised or Mutual Recognition Procedure

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Question 2
Is it possible to submit text proposals for the SPC, PL and Labelling for applications for variations and renewals to marketing authorisation granted via the Mutual Recognition or the Decentralised Procedure in English only?

Member States have agreed to accept text proposals for the SPC, PL and labelling in English with the submission of type II variation and renewal applications, provided that translations of the agreed SPC, PL and labelling were submitted after the end of the Mutual Recognition or Decentralised Procedure for the initial marketing authorisation. Sample mock-ups in an official language of the EU should also be submitted (where appropriate) for the application to be considered valid.
High quality translations of the agreed SPC, PL and labelling should be submitted at the latest 5 days after the end of the type II variation or renewal procedure; however, these may be required earlier in the procedure by some Competent Authorities.
For type IA/IB variation applications, text proposals for the SPC, PL and labelling in the respective national language(s) should be submitted together with the application.

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Consultation with target patient groups for the Package Leaflet

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Question 3
Will consultation with target patient groups be required for medicinal products authorised before the date of entry into force of the new legislation?

Consideration should be given to undertaking consultation with target patient groups, in accordance with Article 59(3) of Directive 2001/83/EC, as amended, for medicinal products authorised before the date of entry into force of the new legislation where further regulatory activity, eg renewal, variation, is planned.

Marketing Authorisation Holders are advised to discuss with the Reference Member State the need to undertake consultation with target patient groups for authorised medicinal products, taking into account that consultation with target patient groups is required at the time of variations introducing major changes to the package leaflet (e.g. new indication, use in a new target patient group, novel presentation with critical administration issues). Harmonisation of the package leaflet may also result in consultation with target patient groups being required if several changes are introduced together that substantially change the approved leaflet.

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Question 4
Will consultation with target patient groups be required for medicinal products for which the marketing authorisation has to be renewed according to the new legislation?

Applicants are reminded that the package leaflet agreed at renewal should be in line with the requirements of Article 59 of Directive 2001/82/EC, as amended. Applicants are expected to address this aspect at renewal. However, consultation with target patient groups for the package leaflet is not considered as a condition of renewal, and applicant could ask for submission of these results afterwards in accordance with an agreed timeframe (see also Question 'What should be the procedure for the harmonisation of the Labelling and Package Leaflet for renewals finalised after 30 October 2005?')

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Question 5
Is it possible to justify that a Package Leaflet complies with the requirement of Article 59 by referring to results of consultation with target patients groups on other package leaflets?

The absence of test results from consultation with target patient groups could be justified by referring to another tested package leaflet (the reference PL) provided that the key messages for safe use have been adequately addressed. The package leaflet and the reference PL have to be similar in content, and the design and layout should be considered. The applicant should submit an adequate justification which critically appraises the similarities/differences between the submitted PL and the reference PL and addresses the relevance of test results with the reference PL. In addition, a critical comparison of the design and layout of both PLs should be included.
Justification for absence of consultation with target patient groups by referring to other tested PLs is applicable in all situations (e.g. new applications, renewals, variations) where patient consultation may be required.

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Question 6
What is the timing in a Mutual Recognition or Decentralised Procedure for the submission to the Competent Authorities of the results of consultation with target patient groups for the Package Leaflet, in accordance with Articles 59(3) and 61(1) of Directive 2001/83/EC, as amended?

Applicants are advised to consider the need for ‘user consultation’ in advance of the submission of applications for marketing authorisation via the Mutual Recognition or Decentralised Procedure and undertake initial testing as necessary and/or consider the timing of consultation within the procedural timeframe. Applicants should present the results of the user consultation or justification for their absence in Module 1.3.4 of the application, in accordance with the document: Guidance concerning “consultation with target patient groups” for the package leaflet, available on the European Commission website.
http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2005/08_05/USERTESTING_20050817.pdf
There are further opportunities within the procedural timeframes to submit the results of user consultation. The objective is to have reached agreement on a harmonised label and package leaflet at the completion of the procedure.
For further information on the timing of user consultation, submission and assessment within the evaluation procedure in the Decentralised or Mutual Recognition Procedure, please refer, respectively, to the Decentralised procedure – Member States SOP and to the Best Practice Guide for the Mutual Recognition Procedure, available on the Heads of Agencies website.

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Question 7
What should be the procedure to harmonise the Labelling and Package Leaflet of a MR medicinal product where the repeat-use procedure is to be used after 30 October 2005?

Harmonisation of the labelling and package leaflet of a medicinal product should be achieved using a Type II variation before the start of the repeat-use MRP.
There is also the possibility to make use of an Article 61(3) notification procedure where minor changes only to the labelling and package leaflet are required, but Marketing Authorisation Holders are advised to discuss such possibility with the Reference Member State ahead of submission (CMS involvement may also be necessary).

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Question 8
Will there be any transitional period for the harmonisation of the Labelling and Package Leaflet of medicinal products authorised via the Mutual Recognition Procedure before 30 October 2005?

The recommendation of the CMDh is for Marketing Authorisation Holders to harmonise the Labelling and Package Leaflet of existing medicinal products as early as possible (at the time of a major variation or renewal procedure) and to contact the Reference Member State on this regard.
Applicants are informed that the proposals for a harmonised labelling and package leaflet can be only dealt with during these procedures, if they are submitted at the start of the procedures.

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Question 9
What should be the procedure for the harmonisation of the Labelling and Package Leaflet?

It is possible to submit a single Type II variation in order to update the product information according to the new pharmaceutical legislation.  MSs consider a single Type II variation entitled 'update to comply with the new legislation' acceptable if the MAH wish to address the following items: harmonisation of PL and Labelling (including results from patient consultation, Braille and other formats suitable for blind and partially sighted patients), adjustment of the label (Braille).  Applicants should liaise with the RMS if they wish to make use of the Article 61(3) procedure to introduce these changes.

In addition, following an Article 30 referral procedure for the originator, applicants may use variation No. 46 type 1B to change the SPC, Package Leaflet and Labelling of a generic medicinal product consistent with the Commission Decision.

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Question 10
What should be the procedure for the harmonisation of the Labelling and Package Leaflet for renewals finalised after 30 October 2005?

Applicants are reminded that the new legislation is effective from the date of entry into force. The harmonisation of the Package Leaflet and Labelling will apply for products renewed after 30 October 2005 via the Mutual Recognition Procedure, even if the procedure is started before this date.

Harmonised leaflets and labels should be agreed at renewal if national versions still exist. They have to comply with Article 59 of Directive 2001/83/EC, as amended requiring that the leaflet reflects the results of consultations with target patient groups. We expect that such consultation will be undertaken with the leaflet in its intended layout and format and therefore reflects the needs of patients. Applicants are expected to address this aspect at renewal.  Any plans for a future harmonisation of label and leaflet should be agreed with the RMS, and this may be submitted following renewal as a composite (single) Type II variation, together with the results of consultation with target groups in accordance with an agreed timeframe (see also Question 18 and 19).

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Question 11 (added: January 2010)
Could the requirement in Art. 59(3) of Directive 2001/83/EC, concerning the package leaflet and consultations with target patient groups, be considered fulfilled if the Public Assessment Report (PAR) or European Public Assessment Report (EPAR) of another product containing the same active substance but with a different Marketing Authorisation Holder, reflects that the package leaflet has been subject to an acceptable "user test"?

Yes, provided that the package leaflet of the product applied for follows the same wording as the tested package leaflet. The applicant needs to submit a bridging report in Module 1.3.4 containing:

• a justification including name and procedure number of the product that has already been subject to an acceptable user test;
• evidence of a successful user test (e.g. a copy of the relevant PAR/EPAR)
• proof that the package leaflets follow the same wording (e.g. comparison of the package leaflets);
• a bridging report regarding the design and layout of the package leaflet applied for.

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Braille

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Question 12
Will the requirement of Article 56a of Directive 2001/83/EC, as amended, regarding the inclusion of the name of the medicinal product, as referred to in Article 54, in Braille format on the packaging be applicable to all medicinal products, regardless of the date of the authorisation?

The provision of Article 56a of Directive 2001/83/EC, as amended will apply to all medicinal products authorised after 30 October 2005 (with the exception of medicinal products intended for administration by health care professionals only).
Therefore, applicants are advised to already express the name of the medicinal product in Braille format on the packaging of applications for marketing authorisation to be finalised after 30 October 2005.
For medicinal products authorised before 30 October 2005, Marketing Authorisation Holders are encouraged to apply this provision to all relevant medicinal products as soon as possible and to contact national competent authorities on this regard.
For further information, please refer to the Guidance concerning the Braille requirements for labelling and package leaflet, available on the European Commission website http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2005/04_05/braille_text20050411.pdf

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Question 13
What should be considered as the name of the medicinal product for the purpose of complying with Article 56a of Directive 2001/83/EC, as amended?

The name of the medicinal product, as mentioned in Article 1(20) of Directive 2001/83/EC, as amended “the name, which may be either an invented name not liable to confusion with the common name, or a common or scientific name accompanied by a trade mark or the name of the Marketing Authorisation Holder”, followed by its strength.
For medicinal products authorised only in a single strength, it is acceptable that only the invented name is expressed in Braille format on the packaging.
Please note that this interpretation should not prevent Companies from expressing further information (pharmaceutical form and, if appropriate, whether the medicinal product is intended for babies, children or adults) in Braille. In addition, the inclusion of the expiry date in Braille is welcome.

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Public Assessment Reports

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Question 14
In accordance with Article 21(4) of Directive 2001/83/EC, as amended, the Competent Authorities shall make publicly accessible without any delay, the assessment report together with the reasons of their opinion, after deletion of any commercially confidential information.
Will the assessment report for Mutual Recognition and Decentralised Procedures be publicly available? If so, where will assessment reports be published?

The MRFG has agreed to actively publish the assessment report for medicinal products submitted via the Mutual Recognition or Decentralised Procedure and completed after 30 October 2005.
The public assessment report will be available in English on the MRI-Product Index, Heads of Agencies website http://www.hma.eu/mri.html 60 days after the conclusion of the MR or DC Procedure.
The publication of AR in the national languages is the decision and responsibility of national competent authorities.
AR for nationally authorised medicinal products will be made publicly accessible and the respective national competent authority should be contacted on this regard.

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Information on marketing of medicinal products

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Question 15
Will the requirement set out in Article 23a of Directive 2001/83/EC, as amended, to inform the Competent Authority of the authorising Member State of the marketing date of the medicinal product in that MS and of the interruption in the placin on the market be applicable to all authorised medicinal products, regardless of the date of authorisation?

The requirement to inform the Competent Authority of the date of actual marketing of the medicinal product in that Member State and of any temporary or permanent interruption of such marketing will apply to all medicinal products authorised as of the date of implementation of the new legislation.
For existing medicinal products, the three-year period of non-marketing, which may lead to the marketing authorisation ceasing to be valid (‘sunset clause’) will start to be counted from the date of implementation of the new legislation.
Marketing Authorisation Holders will therefore have to inform the Competent Authority of the marketing status of all presentations of the medicinal product in that Member State in accordance with national arrangements.
Marketing Authorisation Holders of existing medicinal products shall also notify the Competent Authority of any temporary or permanent interruption of such marketing in accordance with national arrangements.
For further information on the application of the “sunset clause”, please refer to the European Commission website
http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2005/10_05/sunsetclause_10-2005.pdf

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List of Mutual Recognition products

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Question 16
Are medicinal products authorised by MRP or DCP listed?

Yes they are listed in the MRI Product Index, available in the Heads of Agencies website at the following web address: http://www.hma.eu/mri.html

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Question 17
Are pending applications for MRPs or DCPs listed?

No, they are not listed because the information is confidential.

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Question 18
Are CMS where applications have been withdrawn, listed?

No, they are not listed because this information is confidential.

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