, COSTA RICA – Harmonization of Pharmaceutical Products

COSTA RICA – Harmonization of Pharmaceutical Products

On Thursday, June 30, 2022, decree number 43590-S called “Requirements and procedures for the approval and recognition of the Sanitary Registry of Pharmaceutical Products granted by the member authorities of the International Council” was published in the Official Gazette. Harmonization of Technical Requirements for Pharmaceutical Products for Human Use (ICH) for its acronym in English.

From this Decree, the term for registration of pharmaceutical products goes from one year to only 30 days.

The intention of the current Government of Costa Rica is that if a person consumes this medicine in another ICH member country and it is verified by a laboratory and has a health registry, they can do it in the same way in our country.

Which regulatory authorities are part of the ICH?

  • EMA (European Community, Europe): for products approved by centralized and decentralized procedure, FDA, United States, MHLW/PMDA, Japan.
  • HealthCanada, Canada.
  • Swissmedic, Switzerland.
  • ANVISA, Brazil.
  • COFEPRIS, Mexico.
  • HSA, Singapore.
  • MFDS, Republic of Korea.
  • NMPA, China.
  • SFDA, Saudi Arabia.
  • TFDA, Chinese Taipei.
  • TITCK, Turkey.

Among the requirements that must be met as indicated in the decree are:

  • Payment of fee.
  • Request for registration recognition signed and stamped by the responsible professional and the owner or his legal representative.
  • Powers of attorney duly legalized proving legal representation, granted by the owner.
  • Certificate of original pharmaceutical product, issued by an ICH authority, apostilled and legalized.
  • Affidavit signed by the legal representative of the owner of the product in Costa Rica, confirming that the product and the pharmaceutical forms to be registered are those approved by the ICH regulatory authority.
  • Complete copy of the file together with a sworn statement signed by the legal representative of the owner of the drug in Costa Rica
  • Stability study according to the RTCA of Pharmaceutical Products.
  • Label of the primary, secondary and insert packaging in original or its projects, in accordance with the RTCA of Pharmaceutical Products.

For some sectors of the population, this homologation and simplification of procedures could bring about a reduction in the cost of medicines, however, for the medicine industry this is not a guarantee.

From the point of view of Sanitary Registries, putting an end to the bureaucracy and excessive paperwork of Public Institutions will always be beneficial for the country.

At CENTRAL LAW we can support you with the process of sanitary registration of pharmaceutical products in Costa Rica.

For more information, contact us at: info@central-law.com


Ricardo Rodríguez V.

Director de Propiedad Intelectual

CENTRAL LAW in Costa Rica.

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