Brexit Combination Product Regulatory pathway for UK (MHRA).

Nanda06

Registered
Hello,


Can someone help me on below query regarding UK Combination product requirements.


Product is a combination Drug + Device (Syringe). As far as my understanding, for EU it is considering under combination product category as per Directive 2001/83/EC. Device (Syringe) technicalities will be assed through “Notified Body Opinion” prior to the EMA submissions.


Please help me to share the combination product Regulatory pathway for UK (MHRA).


Regards
Nanda
 

Simona F.

Registered
Hello all,

I'm looking for support in understanding how MHRA classifies a drug-device combination product: PMDI - Pressurized Metered Dose Inhaler.
In particular:
is there a document/position paper to understand which part of this product is considered the "medical device constituent part" for MHRA?

Thanks so much in advance for your replies.

Kind regards,
Simona
 
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