Q & A’s From Webinar: How to Accelerate Your Medicinal Product launch in EU? – Topic: Orphan drug/EAP/PIP

2 June 2021

garnier.yasmine@blue-reg.com

Over the last weeks, we've been 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 4/4 - Topic: Orphan Drug/EAP/PIP

 

Question 16:

 

We have an orphan drug in development, is there anything special we need to consider for launch?

 

Nadia Boehringer:

 

'Well, in Europe, an orphan drug requires registration through the centralised procedure. As presented in the webinar, all the European and local requirements must be fulfilled to be able to launch your product in the concerned country. Most of the time , for such a launch, the applicant wants to set up a specific early access program for key markets. It’s exactly the kind of product for which you need to think about several strategies, starting with EAP, then when EC decision is issued, start the transition phase up to the real commercial launch.

 

You may also need to consider specific distribution for orphan depending of the nature of your products. In any case, as I said, I recommend to start working on the launch sequence as soon as possible. Depending on the registration process (accelerated or classical pathway), this can have an impact on your strategy to market the drug.'

 

Question 17:

 

Can you outline how you would plan in a bit more detail the transition period? What should my team consider or should we maintain EAP whilst we launch in other countries?

 

Nadia Boehringer:

 

'In terms of process, if your company is considering an early access program this must be part of the launch sequence as I just said. Depending upon the country regulations, and the product, and where you are in the registration procedure, the EAP can be set-up in some markets. Here again the country requirements are not the same and are country dependant. An EAP can be set-up in one country, free of charge on a named patient basis local regulation, whereas in the second country, it can be considered as a cohort early access program which will be covered by health insurance. The transition to a commercial launch will be determined by the local law in terms of timing and requirements. In each country launch, using EAP first, should be carefully studied in terms of constraints and future impacts for your market.'

 

Question 18:

 

Is there anything special concerning paediatric requirements that we need to consider for our launch?

 

Nadia Boehringer:

 

'The paediatric requirements have no impact on the launch. The paediatric requirements are the requirements which must be met to obtain a marketing authorisation. Depending on your product, a paediatric indication can be approved, but this has no impact on your launch. The launch timings of your presentations is often a decision taken in conjunction with marketing and the patient need.'

 

If you have any questions please do not hesitate to contact us !

garnier.yasmine@blue-reg.com

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