On April 1, 2020, the Costa Rican Health Ministry executed the directive DM-RM-0838-2020, related to the Administrative Regulations pertaining Registration, Renovation and Post-Registration Changes of Products of Sanitary Interest on the governmental platform “Registrelo”. These are some of the regulations issued in said directive:

  • The validity of the registers of products of sanitary interest is extended for six months in a progressive manner as shown below:

Current Due Date

New Due Date

April 2020

October 30th, 2020

May 2020

November 30th, 2020

June 2020

December 30th, 2020

July 2020

January 30th, 2021

August 2020

February 28th, 2021

September 2020

March 28th, 2021

 

 

 

 

 

 

 

 

 

 

  • The deadlines for dealing with these procedures are maintained, which means, they will not be expedited or delayed.
  • Requests for post-registration changes that are already filed and that have been prevented, may request a three-month extension for the management of documents from other Regulatory Authorities that will require apostille or legalization. If at the end of the extension period the apostille or legalization is not achieved, simple documents shall be provided accompanied by a letter digitally signed by the Legal Representative of the requesting company where he/she agrees to deliver the apostilled documents by a post-registration change within a period not exceeding six months from the approval of the respective change.
  • For new requests for post-registration changes that are filed as of April 1 and that do not have the apostilled or legalized documents, a letter digitally signed by the Legal Representative of the requesting company must be included where they agree to include by means of a post-registration change said documents duly legalized, in a period not exceeding six months from the approval of the respective change.
  • New applications for registration of products of sanitary interest of foreign origin that are filed from April 1, must present all the documentation established in the current regulations for the corresponding type of product. The Certificates of Free Sale and of Good Manufacturing Practices can be replaced by a notarized certification of digital document copy of the online database of Regulatory Authorities where such information is displayed. The Notary must record the electronic address where the document is located, as well as the date of consultation. If the document is in a language other than Spanish, the corresponding official translation must be attached.
  • For all types of national product procedures, all the requirements established in the current regulations for the type of product to be registered must be filed.

 

 

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