+38 044 332-42-94,
+38 044 221-71-29,
Medicines: human drugs and biologics
— Market requirements for medicines
— Establishment of new registration
— Variations (changes)
— Renewal of registration
— Inspection of manufacturing site
— Pharmacological vigilance
— State registry of medicines
— Ukrainian legislation
— Our partners

Variations (changes)

During validity of marketing authorization certificate all changes and amendments to registration materials should be approved by State Expert Center. As a result of such approval Applicant obtains annex to registration certificate that confirms that variations have been approved.

Depending on the content of changes variations can be classified as type Ia, Ib, II or variations that require new registration. Classification of the variations is performed according to Order 426, therefore it is almost completely harmonized with EU “Guideline on dossier requirements for Type IA and IB notifications”.

Variations process is initiated by submission of the Application. Depending on the content of variations relevant documents should amend the Application. Each separate variation requires submission of separate Application with relevant justifying documents.

Variations (changes) | Cratia There is no procedure of “just notification” of state authority for variations type Ia and Ib. Even the minor variation requires expertise process, communication with state authority and other administrative actions, official approval of the variation on the session of State Expert Center till issue of annex to registration certificate.  

Official timing of state expertise of variations types Ia, Ib and II is limited by 60 days not including timing required by Applicant for answers on deficiency letters.

State fee (payment for expertise of variations) should be paid before expertise of registration materials according to relevant Invoice of State Expert Center.

Variations (changes) | Cratia 2 We offer comprehensive service of introducing of variations to marketing authorization certificate. All works will be performed by big professional and experienced team of regulatory professionals, chemists and doctors. We provide our knowledge and experience to many companies and have necessary capacities for new projects. Cratia has all necessary permissions and accreditations for all in-process activities.

 

You can contact us by e-mail info@cratia.ua, telephone +38 (044) 332-42-94, 221-71-29 or at the meeting in our office.