Q & A’s From Webinar: How to Accelerate Your Medicinal Product launch in EU? – Topic: Launch

19 May 2021

garnier.yasmine@blue-reg.com

Over the next three weeks we will be sharing all the Q & A's from our previous Webinar on 'How to accelerate your medicinal product launch in Europe'. We have divided the Q & A's into 4 main topics.

 

Week 2/4 - Topic: Launch

 

Question 7:

 

My supply chain have no experience of serialisation, when do you recommend we initiate the planning for this?

 

Anne-Valérie Faucher:

 

'Serialisation impact different departments and sites. At the minimum the manufacturing site, the supply chain team, the regulatory affairs team and the IT team. The planning must be initiated as early as possible with the supply chain and manufacturing site, and in parallel to that, the Marketing Authorisation Holder must be registered at the European and at local level (in country of interest). The registration at European level takes around 2 months and at local level between 2 to 6 months and when the registration is completed the manufacturing site can start some pilot tests to be ready on time.'

 

Question 8:

 

in terms of local databases, do you recommend inclusion in all databases at a local level?

 

Anne-Valérie Faucher:

 

'When the databases are optional, it’s a company decision to register the product in these databases. Decisions are generally aligned to the commercial strategy. On one hand you have to pay for these optional databases and the information must be kept up to date but on the other hand it can give to your product visibility for Health care professionals. The use of databases should be evaluated on national level where these are not mandatory in order to assess the importance of registered in these.'

 

Question 9:

 

For serialisation, in Italy you mention the bollino. Can you expand on this, is it a code?

 

Anne-Valérie Faucher:

 

'The Italian bollino is an optical sticker carrying the product name, the strength, the pharmaceutical form, and the concerned local code. The sticker is then stuck to the packaging. To obtain the bollino, some local steps must be completed in the Italian dedicated platform in local language. In practice, the manufacturing site which is authorised to undertake the secondary packaging operations is able to add the sticker on the carton. It is very important to make aware your manufacturing site on this specific sticker, nonetheless, sometimes this activity is performed in Italy at a dedicated registered site for adding the bollino.'

 

Question 10:

 

For educational materials, do you have any tips for this part of the process as we are about to start local translation of our materials?

 

Anne-Valérie Faucher:

 

'Like for the product information translations, the quality of the translation of the educational materials must be very high quality. All the local requirements must be fulfilled (such as the blue hand in the German document). The regulatory affairs team must work on these documents in close collaboration with the medical and pharmacovigilance teams. A global implementation plan can be drafted to be used as a basis for the local implementation plan. All the good manufacturing practices for pharmacovigilance must be followed. The use of educational material is followed closely by the EMA and the national agencies. During a Pharmacovigilance inspection the implementation & follow-up of educational materials can be subject to investigation by inspectors.'

 

Question 11:

 

MHRA vetting, you mentioned it is not always required? Can we anticipate it would be required in advance for our product?

 

Anne-Valérie Faucher:

 

'Brexit as no impact on advertising materials, all the rules are common for Great Britain and Northern Ireland. In the United Kingdom, advertising materials for certain products may be required to be submitted for assessment by the MHRA prior to issue, this is called the vetting process. There are two, no sorry tree main cases where vetting may be required:

 

- Newly authorised products subject to additional monitoring and for all new active substances

- Products which are reclassified (OTC switch procedure in other words from “prescription only medicine or POM status” to “pharmacy or P status” medicine)

- When previous advertising for a product did not follow the regulations

 

The MHRA will inform the Applicant when vetting will be applicable for their product. For example, during a registration procedure, the Applicant will receive an email from the advertising department from the MHRA about the need of vetting for their product.

 

The period of vetting will normally be 1 to 3 months and would normally not extend for longer than 6 months. This time period may be reduced or extended depending for example on the quality of the advertising submitted.

 

Brexit as no impact on advertising materials, all the rules are common for Great Britain and Northern Ireland. In the United Kingdom, advertising materials for certain products may be required to be submitted for assessment by the MHRA prior to issue, this is called the vetting process. There are two, no sorry tree main cases where vetting may be required:

 

- Newly authorised products subject to additional monitoring and for all new active substances

- Products which are reclassified (OTC switch procedure in other words from “prescription only medicine or POM status” to “pharmacy or P status” medicine)

- When previous advertising for a product did not follow the regulations

 

The MHRA will inform the Applicant when vetting will be applicable for their product. For example, during a registration procedure, the Applicant will receive an email from the advertising department from the MHRA about the need of vetting for their product.

 

The period of vetting will normally be 1 to 3 months and would normally not extend for longer than 6 months. This time period may be reduced or extended depending for example on the quality of the advertising submitted.'

 

Question 12:

 

You mentioned that for Great Britain, the registration process is different. What about the launch? Does that trigger additional challenges too?

 

Anne-Valérie Faucher:

 

'Due to Brexit, the situation is a little bit complex for the moment being in Great Britain. Some guidelines are not available at the MHRA level, such as the serialisation guideline. Thus, if you plan a launch in the coming months or years it is important to check the MHRA website to find any news and useful information linked to your launch. But keep in mind that MHRA is a very pragmatic agency, thus if you plan a launch for example in Q four two o twenty-one, you can discuss with MHRA to find a solution for your own product, maybe you will be allowed to import a Northern Ireland pack as example.'

 

Question 13:

 

You never mentioned Switzerland during the presentation, so what about a launch in Switzerland ?

 

Anne-Valérie Faucher:

 

'In fact, even if Switzerland is geographically located in the Europe, Switzerland is not part of any European procedure, and to be able to commercially launch your product in Switzerland, you need to obtain a local Swiss marketing authorisation. The Swiss rules to obtain a marketing authorisation are similar to the European regulations, and if your product has obtained a marketing authorisation through a centralised procedure, your Swiss assessment might be prioritised meaning that the Swiss data file is generally submitted by companies after receiving European approval. Market launch requirements will need to be planned as discussed in the presentation in order to take into account the national Swiss launch requirements.'

 

If you have any questions please do not hesitate to contact us ! See you next week for the next article: 'Q & A's From Webinar: How to Accelerate Your Medicinal Product launch in EU? - Topic of the week: Shared Packs/Blue Box'

garnier.yasmine@blue-reg.com

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