Variations

Here there is a list of the administrative and CMC variations that require notification and approval from the Argentinean health authority, and the list of documents to submit.

Change of excipients

Variation form
Notary-authenticated copy of certificate
Fee
Sworn statement declaring that the requested variation won’t change the finished product stability, the analytical methods, nor require any change in the manufacturing process.

Change of manufacturer (only for finished product)

If the change is from a manufacturer in Argentina to another manufacturer in Argentina

Copy of authorization certificate of the new manufacturer
Copy of authorization certificate of the solicitor
Variation form
Notary-authenticated copy of certificate
Manufacturing agreement signed by technical directors and legal representatives; signatures must be certified.
Fee

If the change of manufacturer involves a manufacturing plant outside Argentina (process must be filed under the “new alternative origin country” case)

– If the change supposes that a registered article 3, 4 or 5 product becomes an article 5 product:

Form
Sworn Statement declaring that labeling text will be the same that already authorized
Evidence of commercialization of product made in new manufacturer in at least one Annex I country
Authenticated copy of original certificate
Fee

– If the change supposes that a registered article 3 or 5 product becomes an article 3 product:

Form
Sworn Statement declaring that labeling text will be the same that already authorized
Sworn statement declaring that the methods of manufacturing and control and the shelf life won’t be modified and will be those currently authorized by ANMAT.
Evidence of commercialization of product made in new origin country in new origin country
Approval of manufacturing site in new origin country
Authenticated copy of original certificate
Fee

– If the change supposes that a registered article 4 product becomes an article 3 or 5 product:

Form
Sworn Statement declaring that labeling text will be the same that already authorized
Manufacturing method
Control methods
Stability studies
Evidence of commercialization of product made in new origin country in new origin country
Approval of manufacturing site in new origin country
Authenticated copy of original certificate
Fee

– If the change supposes that a registered article 5 product becomes an article 3 or 5 product:

Form
Sworn Statement declaring that labeling text will be the same that already authorized
Sworn statement declaring that the methods of manufacturing and control and the shelf life won’t be modified and will be those currently authorized by ANMAT.
Authenticated copy of original certificate
Fee

– If the change supposes that a registered imported article 3 or 5 product will be manufactured in Argentina:

Form
Sworn Statement declaring that labeling text will be the same that already authorized
Sworn statement declaring that the methods of manufacturing and control and the shelf life won’t be modified and will be those currently authorized by ANMAT.
Authenticated copy of original certificate
Authenticated copy of authorization certificate for the manufacturing site.
Fee

– If the change supposes that a registered imported article 4 product will be manufactured in Argentina:

Form
Sworn Statement declaring that labeling text will be the same that already authorized
Manufacturing method
Control methods
Stability studies
Authenticated copy of original certificate
Fee

– If the change supposes that a registered product manufactured in Argentina becomes an article 4 product:

Form
Sworn Statement declaring that labeling text will be the same that already authorized
Evidence of commercialization of product made in new origin country in at least one Annex I country
Authenticated copy of importing license
Authenticated copy of original certificate
Fee

– If the change supposes that a registered product manufactured in Argentina becomes an article 3 or 4 product:

Form
Sworn Statement declaring that labeling text will be the same that already authorized
Sworn statement declaring that the methods of manufacturing and control and the shelf life won’t be modified and will be those currently authorized by ANMAT.
Approval of manufacturing site in new origin country
Authenticated copy of importing license
Authenticated copy of original certificate
Fee

Change of corporate name of manufacturer (only for finished products)

Legalized copy of representation power from headquarters to local affiliate
Legalized copy of letter for the legal representative of the new corporate entity informing the new structure.
Legalized copy of product certificate.
Variation form
Fee

Labeling changes

If the change is in one or some of the following sections: Warnings, Contraindications, Adverse Reactions, Precautions, Interactions or Overdose:

DJMP form (Labeling Modification Sworn Statement)
Notary-authenticated copy of certificate
Copy of last approved labeling texts
New labeling texts with track change marks
Three copies of new labeling texts
Sworn statement

If the change is in an item different than the mentioned above, then a fee must be payed and the requested documents are the following:

Notary-authenticated copy of certificate
Justification documentation
Copy of last approved labeling texts
New labeling texts with track change marks
Three copies of new labeling texts
Fee

If the change includes a new indication:

Notary-authenticated copy of certificate
Copy of last approved labeling texts
New labeling texts with track change marks
Three copies of new labeling texts
Evidence of marketing in an Annex I country (with new indication)
Fee

Shelf life extension

Notary-authenticated copy of certificate
Certificate from origin country, specifying requested new shelf life (only if available, for imported products)
Stability data – Representative chromatograms of the study might be requested.
Finished product specifications and analytical methods
Fee

Change of marketing condition

Variation form
Notary-authenticated copy of certificate
Three copies of new labeling text
Evidence of marketing of a similar product marketed in Argentina or an Annex I country under the requested marketing condition.
Fee

Marketing authorization transfer

Contract of certificate transfer signed by legal representatives and technical directors of both companies.
Copy of authorization certificate of site and corresponding disposition
Copy of technical director dispositions
Copy of representation powers of legal representatives
Filled format detailing product certificates affected by the change
Legalized copies of those certificates
Diskette containing the following information: drug product, drug substance, certificate, validity, pharmaceutical form, owner and representation
Variation form for each certificate
Copy of sworn statement of certificates of marketed products
Fee

New primary packaging material

Variation form
Notary-authenticated copy of certificate
Stability data
Fee
Sworn statement declaring that the requested variation won’t affect the finished product shelf life, the analytical methods, nor require any change in the manufacturing process.

Last update: October 2013