The “Regulations to determine the Maximum Sales Price for Medicines and its verification” and “General Regulations of the Medicines Law” entered into force in El Salvador.

Dear Clients:

We hereby inform you that on December 29, 2012, the  “Regulations to determine the Maximum Sales Price for Medicines and its verification” and “General Regulations of the Medicines Law” entered into force.  For further information, or if you require the authorized List of Prices for Medicines (Listado de Precios de Medicamentos (publicado en el DO del 3 de Enero), scheduled to be published in the Official Gazette of January 3, 2013, which will be sold on approximately 15 days.  , please contact Marcela:

Marcela Mancia / Partner: marcela@romeropineda.com

Pamela Giraldo / Associate: ip5@romeropineda.com

 

INFORMATION OF INTEREST

 

Legislative Decree No. 1088 of February 22, 2012, containing the “Medicines Law”, sanctioned by the President of El Salvador on March 02, 2012, established the responsibility to draft the regulations required for the application of such Law, by which on December 17 and 18, 2012, Legislative Decree No. 244 “Regulations to determine the Maximum Sales Price for Medicines and its verification” and Legislative Decree No. 245 “General Regulations of the Medicines Law” where sanctioned.

 

The main objective of the “Regulations to determine the Maximum Sales Price for Medicines and its verification” is to establish, review and verify the maximum sales price of the medicines that are not of free sale. Some of the principal issues included in the regulation are:

 

  1. The formula for the estimation of the Maximum Sales Price to the Public was established.
  2. Annually, the National Medicines Bureau will publish the list of maximum sales prices to the public.
  3. The products must have a label or print in the package with the sales price of the product and the maximum sales price to the public.
  4. Pharmaceutical establishments will have a maximum of 90 days to adapt the maximum sales price of the medicines to the public.
  5. Pharmaceutical establishments may prepare a sworn declaration and an inventory of the medicines in stock at the date this regulation enters into force, having a maximum term of eight days after the regulation is in force to file the same before the National Medicines Bureau, this is until January 05, 2013. If this is not done, the National Medicines Bureau will understand that the pharmaceutical establishments will sell drugs to the public at the Maximum Sales Price.

 

The main objective of the “General Regulations of the Medicines Law” is to develop and complement the Medicines Law in the following aspects:

  1. The structure and tasks of the Units that compose the National Medicines Bureau.
  2. Determine the unit in charge and the requirements to obtain the registration of pharmaceutical products, medical supplies, cosmetics and hygiene products.
  3. Establish the requirements for the import, export and donation of medicines.
  4. Determines the general requirements for the different pharmaceutical establishments that manufacture and distribute products, such as: Pharmacies, Hospital`s and Medicine Cabinets and Pharmacies; Pharmaceutical Products Distributors or Drug Stores;  Laboratories for Pharmaceuticals, Cosmetics and Hygiene Products; Quality Control Laboratories and Supermarket and Market Displays, among others.
  5. Rules the obligations and responsibilities of the Professional Pharmaceutical Chemist that every pharmaceutical establishment must have.
  6. Stipulates the requirements to advertise and publish medications that are sold over the counter.
  7. Regulates the minimum necessary information for the products labeling and packaging.
  8. Rules the inspection and supervision process to verify the conditions of storage, distribution, transportation, sale, sanitary registration, quality control and drug prices.

The regulations will be in force 8 days after their publication in the Official Gazette, which was December 20th 2012.

For further information or if you require DRUGS PRICES LIST , do not hesitate to contact Marcela Mancia, Partner of the Intellectual Property Division and / or Pamela Giraldo, Health Registrations Unit Coordinator at (503) 25055555 or via email: marcela@romeropineda.com and/or  ip5@romeropineda.com. It will be a pleasure to assist you.

You can also see the DRUGS PRICE LIST here: Listado de Precios de Medicamentos (publicado en el DO del 3 de Enero)

Sincerely,

ROMERO PINEDA & ASOCIADOS

 

 

 

 

 

 

 

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