Introduction of amendments to the registration dossier of medicines and medical products

This procedure involves changing the data of a previously registered medicine or medical product. The changes made should not reduce the safety and quality of the product.

 

The changes are classified into:

✓ Type I changes that do not require a new registration, changes relating to amendments to the content of the registration dossier, in accordance with Annex 10 to the Rules

✓ Type II changes requiring a new registration: changes not listed in Annex 10 to the Rules relate to type II change and require a new registration

Types of changes made to the registration dossier:

✓ Changing the content of the production license: changing the name of the manufacturing factory

✓ Changing the name of a medical product and / or medical equipment

✓ Change (increase/decrease in names and/or replacement) in accessories structure and/or components and/or consumables

✓ Adding/deleting indications for use; scopes; contraindications; adverse effects

1) Change of manufacturers of medical products intended for prepackaging, processing of final packaging and labeling of medical devices; accessories and (or) components and/or consumables and/or Change in the production site of the manufacturer of a medical product intended for prepackaging, processing, final packaging and labeling, accessories and/or components and/or consumables

2) Increase/decrease of the shelf life of a medical device

3) Change in storage conditions

4) Change in the quality control procedure for the finished product of a medical device

5) Change in the packaging of a medical device: the primary packaging of a medical device; secondary and/or group packaging

✓ Change of imprints, primer or other markings, stamps and inscriptions, including addition or alteration of the paint used for labeling