Brexit Combination Product Regulatory pathway for UK (MHRA).

N

Nanda06

Registered
#1
#1
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
 
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Simona F.

Registered
#2
#2
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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