13 nov 2019 amsterdam - heads of medicines agencies: about …€¦ · • multilingual labels...

Classified as internal/staff & contractors by the European Medicines Agencypatients • quality • value • sustainability • partnership

CMDh & Interested Partiesmeeting

Presentations 13 Nov 2019 Amsterdam

Classified as internal/staff & contractors by the European Medicines Agency

Multilingual labels


Agenda

• Multilingual labels increase access to medicines

• Best practices: Baltics and Nordic countries at the forefront

• Main challenges: National requirements, Approval timelines, Available space

• Short and long-term solutions


Baltics and Nordics at the forefront

• Good cooperation and alignment between the Regulatory Authorities, reflected in guidance documents on common labelling

• Short national approval phases after EU part of a procedure, allowing MAH to give consolidated responses

• Very limited and similar list of national requirements

• Harmonised common serialization labelling standards


Promoting wide use of Multilingual will improve the supply chain of medicines

within the EU Single Market

Multilingual labels can offer significant benefits to patients living in countries where the size of the

market is not big enough to respond to patients’ needs by

• Linking large and small markets

• Increasing resilience of the supply chain


Main Challenges to wide use of Multilingual labels across Europe

General requirements across Europe

Same MAH

Same Products names

Same Legal Basis

Same information in PIL and Mock-up

Main Challenges

• Different approval timelines represent a huge obstacle to multilingual labels even in case of use of the same language in the label

• Limited available space to fit all information needed in

o Outer package

o Product information leaflet

o Vial

• When the outcome of NCAs assessment are incompatible, multilingual labels cannot be implemented


Examples of various National requirements• Product names – rules on product names can be different country by country

• Legal basis can be different across EU members states for the same product (Rx, OTC, different prescriptiondescription)

• Packaging - Different pack-size requested among Member States, Unit dose for hospital products, additional trafficwarning symbols, abbreviation, blue-box requirement, interpretation of minimum particulars (vial 10ml)

• PIL requirements – different information required in addition to QRD template, not harmonised text formulation,abbreviations

• Mock-up requirements and assessment, Latin not accepted

• FMD requirements - Market specific GTIN

MAH needs to coordinate and to put in place an advanced planning to be compliant with all requirements and fit with the National timelines for approvals.However in case of incompatible outcomes in the National approvals and huge difference in timelines for approvals of MAH, product names, Variations, Product information and mock-ups, implements multilingual labels is not possible


Recommended solutions

Short term 1. Install a small working group between regulators and industry to find some

quick wins in adapting/harmonising requirements2. Design simple processes to create common labelling for existing

products, especially taking serialisation complexity into account3. Focus on quick wins, like alignment on common blister texts.

Long-term solution

1. Common Guideline on Multilingual labels (“cluster” level, for countries where sharing multilingual label is logical)

2. Electronic product information ePI 3. Digital telematics tools to improve simultaneous communication among

Competent Authorities and MAH


Variations

Medicines for Europe


Updating texts in accordance with RSI

Current Situation

• Some originators change their texts quite frequently, leading generics companies to submit usually IB variations (acc. C.I.2 a) to follow the change.

• However, there are situations where the originator is disaligned although there are not necessarily divergent opinions among member states e.g. where the originator has sold one (national) license to a competitor who is no longer keeping it in line thus forcing generics industry to submit type II variations (see Q&As on variations No. 3.23) although the content has already been agreed during many submissions of the originator.

• This high variation classification suggests higher safety through in-depth assessment but sometimes simply delays access to the latest information.


Updating texts in accordance with RSI

What we would like to discuss:

• In cases where there is certainly no need to discuss the proposed change further (e.g. addition of safety information previously discussed in several procedures) we would like to see a possibility of justifying a Type IB variation.

• A possibility to change the reference product for text updates in the individual countries (using a ERP).

• There are still many molecules for which no harmonised texts are available, the Art. 30 procedure should be continued for the remaining ones (worth the effort).

• There could be a mandatory worksharing procedure for text updates to originator licenses.


Implementation of warningsTexts affected

Annex 1 to the excipients guideline

• With the threshold now being “ZERO” to include warnings for some excipients, we would like to call for some flexibility for the wording in the package leaflet- otherwise, when there are several warnings for the same product, the information could be confusing for patients / consumers.


What are we struggling with ?

• The non-fulfilment of a condition for a classified IA variation leads to the upgrade to a IB variation even without an obvious scientific reason so often MAHs wish to discuss the specific case.

• Art. 5 recommendations and Classification guideline are not updated regularly

• On the other hand, some guidance can be found in several other places

• Consequently, MAHs repeatedly seek RMSs´ advice (that can differ between NCAs)

Our ask: Pre-classification recommendations by Regulatory bodies should be updated/published regularly and in just 1 place.


Supergroup applications in MRP

• Currently, the applicant must contact one of the authorities to be the lead RMS, this process can take some time (at least 14 d acc. to BPG timetable), and this could be an issue in case of IAIN variations as > 2 weeks planning ahead is needed.

• Can applicants expect some flexibility regarding the notification grace period in such cases? Or could a speedier procedure be specified?


Regulatory optimisation: follow up of the meeting in May 2019

Medicines for Europe


ROG - replacement of cover letter for type IA variations

• Conclusion from the meeting: • The CMDh informed Interested Parties that the ROG

initiative on the replacement of cover letters for type IA variations is being taken forward by the CMDh and intended to be implemented until July (pending IT developments). Other ROG proposals (that have been endorsed by HMA/ EMA) such as inclusion of check-list in eAF, were also being considered.

• The dispatch list should also be replaced and reflected by IT-systems.

• Feedback on the progress and next steps would be highly appreciated

13 nov 2019 amsterdam - heads of medicines agencies: about …€¦ · • multilingual labels...

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