Amendments to the registration dossier
We are pleased to offer you a range of services for amendments to the registration dossier of medicines ON “TURNKEY” BASIS!
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- Experience over 10 years!
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All you have to do is send us an e-mail request in which the originals of documents and a list of changes you want to make will be attached.We will conduct the examination of your documents and you will get FREE full comprehensive information about the type of your documents, time and cost of our services and all government payments.
Changes of type 1A and 1B – minor changes related to packaging design, labelling text, increasing of usage, change of address, the name of the drug, ATC code, change of the of substances’ manufacturer, additional substances change, owner of the registration certificate of medicines change.
Changes in the type 2 are more significant. Such changes include temporary changes associated with drug safety, changes in the instructions text in sections – indications, contraindications, warnings, changes in methods of analysis of drugs, etc. In case of the second type changes, an additional testing of quality control methods of the drug and of other studies may be required.
Other changes – addition / deletion, and change for ingredients, change of indications, bioavailability, pharmacokinetics, dosage, administration method.
Amendments of 1 and type 2 are possible in the process of recurrent registration of the medicine.
Amendments of all other changes may be performed only in the process of a new medicine registration.
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