Approval of amendments to the authorization procedure for medicinal products

  • 24.11.2021


The American Chamber of Commerce in Moldova Welcomes the approval of amendments to the authorization procedure for medicinal products 

On 23 November, the amendments to the Regulation on the authorization of medicinal products entered into force. These changes have been widely consulted and developed with the support of AmCham Moldova members.
The amended regulatory framework provides for 3 new rapid procedures for medicines authorization, as opposed to the general 210-day procedure:

[1️⃣] Conditional procedure (for 1 year) for medicines needed in emergencies, including vaccines and medicines needed for diseases of major public health importance.
[2️⃣] Accelerated unilateral recognition procedure for medicinal products authorized by the EMA, FDA, and other countries with stringent regulatory authorities such as Switzerland, Canada, Japan, Australia, and the United Kingdom.
[3️⃣] Collaborative procedure for WHO pre-qualified medicines.

Also, the term of import of medicines for which the Registration Certificate has expired, but the file was submitted for renewal, has been extended to 12 months, the same term being provided for the import of medicines manufactured under the provisions prior to issuing documents certifying the approval of the post-authorization changes.

AmCham is delighted with the new rules approved and the fruitful collaboration with the Medicines and Medical Devices Agency.
 

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