Drug registration in Argentina

Drug registration in Argentina is regulated by Decree 150/1992 and posterior modifications. (link to Decree – Spanish)

For information on registration of biological drug products, please go to this page.

Argentina is a country that relies heavily on decisions made by countries that it considers of ‘high sanitary surveillance’. Thus, the registration process will depend on in what countries a drug product is already being marketed in, regardless of the country of origin or countries where the pharmaceutical is registered but not marketed.

ANMAT made for this purpose two lists of countries, based on the level of sanitary surveillance, called Annex I and Annex II. (these lists are annexes to the drug registration decree) The lists have been created in 1992 and have not been updated ever since. Maybe for this reason, the EU is not considered as a block and some individual EU countries are listed in the two lists, while some others are just left out.

Annex I countries

USA	France
Japan	United Kingdom
Sweden	Netherlands
Switzerland	Belgium
Israel	Denmark
Canada	Spain
Austria	Italy
Germany

Annex II countries

Australia	China
Mexico	Luxembourg
Brazil	Norway
Cuba	New Zealand
Chile	Hungary
Finland	Ireland

The different registration cases are described in the 150/1992 Decree, which classifies products into three categories based on the countries in which they are manufactured and/or commercialized. Each category is described in a separate article of this Decree.

‘Article 3′

Applies to:

• Drug products manufactured in Argentina or in an Annex II country, when there is a similar drug product already registered in Argentina.
• Drug products manufactured in Argentina, with marketing authorization in any Annex I country, even if there are no similar products registered in Argentina.

Summary of documents required for submission:

• Product information: name, formula, pharmaceutical form, pharmacologic classification, marketing condition.
• Technical information: testing standard, specifications, shelf life, manufacturing method, pharmaceutical equivalence evidence.
• Labeling texts (packaging and leaflets)
• If manufactured in an Annex II country: CPP of origin
• GMP certificate from Annex I country or Argentina

Timeline for approval: about 12 months

‘Article 4′

Applies to:

• Drug products with marketing authorization in at least one Annex I country.

Summary of documents required for submission:

• CPP from Annex I country – Marketed status
• Labeling texts (packaging and leaflets)
• Technical information: to be submitted only upon authority request

Timeline for approval: about 10 months

ANMAT relies heavily in high surveillance health authorities (defined as those of Annex I countries) so the procedure for registering drugs that have already been approved and are currently being marketed in those countries is the simplest and generally quicker. The CPP from an Annex I country, stating the marketed status, is the most important document of the submission. Technical information might even not be requested at all.

‘Article 5′

Applies to:

• Drug products manufactured in Argentina, when there are no similar products already registered in Argentina.
• Drug products manufactured in an Annex II country and not marketed in any Annex I country, when there are no similar products already registered in Argentina.
• Drug products manufactured in a non-Annex I, non-Annex II country, and not marketed in any Annex I country.

Summary of documents required for submission:

• Product information: name, formula, pharmaceutical form, pharmacologic classification, marketing condition.
• Technical information: testing standard, specifications, shelf life, manufacturing method, pharmaceutical equivalence evidence.
• Labeling texts (packaging and leaflets)
• If manufactured in an Annex II country: CPP of origin
• GMP certificate from Annex I country or Argentina
• Safety and efficacy evidence

Timeline for approval: not less than 3 years

In Argentina, once granted the registration, the product certificates expire in 5 years. Go to: Drug product registration renewal in Argentina

Both when products are manufactured locally and when they are imported from other countries, quality check is required for local product release. The quality control duties can be performed by the manufacturing or importing company, or by an authorized third party.

For the first product release of new drug products, or after variations that could affect the quality of a locally manufactured or imported drug product, a procedure known as first batch verification applies.