Author: Laura Fuentes
Head of Life Sciences in El Salvador
Throughout history there have always been situations that require the support of countries, communities or altruistic organizations to meet the basic needs of the population such as food, drinks, housing, medicines, clothing, etc., since having access to these it is limited or nonexistent in some places and for thousands of people, a situation that is to be eradicated through the implementation of the SDGs worldwide.
In this article we will talk about the donations of medicines and related in El Salvador, which in view of the current situation (Covid-19 Pandemic) we have seen and heard have increased with the help of different countries, companies or global organizations to counteract the impact on our vulnerable country. Although these donations are not a definitive solution, they do contribute to reducing the problems of access to medicines. Therefore, they play an important role in health cooperation activities carried out from industrialized countries.
Some important aspects to consider when making a donation:
- The donation must produce the maximum benefit for the recipient.
- The needs expressed by the receiver and his authority must be respected.
- Donated medicines must meet the same quality criteria recognized in the donor country.
- There has to be effective communication between donors and recipients.
These guidelines help pharmaceutical market players to make effective use of scarce resources and to cover basic needs.
The donation of medicines is so important that the World Health Organization (WHO) has established a series of guidelines for delivering medicines in countries that have suffered natural disasters or are in a situation of conflict. Among them, one of the most important is, of course, not to wait for the drugs to go bad.
In El Salvador, the entity in charge of managing donations of medicines and medical devices is the National Directorate of Medicines, which within its reference documents has a Guide for the Entry of Donations of Medicines and Related Products, formulated and adapted taking as based on the guidelines established by the WHO. The purpose of these guidelines is to improve the quality and use of donations of medicines and related products, refraining at the same time from hindering their entry process.
The guide generally contemplates the guidelines, requirements and steps to follow, for all private or governmental entities that intend to bring donations of medicines and related products into the country, it is also intended to technically complement current national regulations, having as a legal basis the Medicines Law, the General Regulation of the Medicines Law and the Central American Technical Regulation 11.03.59.11 Pharmaceutical Products Medicines for Human use; considering that an exception can be made for medicines and products for donated purposes due to officially declared national emergency and sudden outbreaks of rare or newly appearing diseases.
General prerequisites for the authorization process for the entry of donations of medicines, biological products, vaccines and related products:
· Original and copy of form (C02-RS-01-UIEDM.HER06)
· List of medications according to the tool format (C02-RS-03-UIEDM.HER03)
· Original letter of acceptance from the donee.
· Original and copy of the Certificate of Donation.
· Original and copy, when applicable, of the Official Gazette.
General Guidelines to follow for the evaluation of donations:
· Embassies, non-governmental organizations, churches and parishes; They must be legally established in the country, that is, they must be empowered and legally constituted in accordance with the legal and regulatory provisions of the competent authorities.
· Applications for donations from government entities must be stamped and signed by the entity's owner.
· For each vaccine donation income, the National Medicines Directorate will verify the cold chain at customs and will notify the user that prior to the distribution of the vaccine they must carry out the batch release process.
· For the entry of products that require a cold chain, it must be preserved.
· Products that request entry into Salvadoran territory must not have an expiration date of less than 6 months.
· The products that enter for the regulation of this Directorate must not be prohibited in our country.
· The entry of products whose packages are open or have been partially used is not allowed.
· The active ingredient must be duly registered in the country.
· It is the responsibility of the Unit for Imports, Exports and Donations of Medicines to request supporting technical documents to expand information such as technical data sheets, safety data sheets, photographs/images of the products or explanatory letters of the product description, signed by the legal representative of the entity.
Regarding the information in the documentation, it must be indicated how the medicine will be used: Medical Brigade, Health Establishment or other.
For the Certificate of Donation, it should be considered that it contains the following information:
· Identification of the Donor.
· Identification of the donee.
· Product declaration (medicines, medical supplies and/or related products).
· Clear statement that the product is to be donated.
The Grantee's acceptance letter must be submitted in original and must include:
· Identification of the donee.
· Signature of the person in charge of the products.
· Confirmation of acceptance of the donation.
It can be included in the supporting documentation, if applicable, the official journal that must include the Identification of the donee, Validity of the function of the entity and the Name of the Legal Representative or President.
Among the documents to present for donations of medicines, biological products, vaccines, medical supplies, medical equipment, cosmetics, hygienic products and chemical products are:
| Drugs, Biologicals and Vaccines | Quantity Trade Name Active Ingredient Presentation Pharmaceutical Form Lot Expiration Date Country of Origin or Origin |
| Medical Supplies, Cosmetic Products, Hygienic Products and Chemical Products | QuantityBrandPresentationExpiration DateBatchCountry of Origin or Origin |
| Medical equipments | QuantitySerial NumberCountry of Origin or Origin |
Procedure to request the entry of Donations:
Step 1: The user must present the prerequisites for the authorization process for the entry of donations of medicines, medical supplies and related products to the Unit for Imports, Exports and Donations of Medicines.
Step 2: If all the documentation submitted is complete, the application will be considered as submitted. Otherwise, the observations will be delivered immediately to the user, in order to comply with the provisions.
Step 3: Once the request is entered, a response will be given in a maximum of 4 business days from the day after the request is submitted. (The time is suspended when there are observations and resumes when the correction of said procedure is sent).
Step 4: Withdraw the donation authorization in the Medicine Import, Export and Donation Unit.
For more information contact the author of this article:
Laura Fuentes – Life Sciences Pharmaceutical Chemist lfuentes@latinalliance.co
Or to Olga Torres, Regional Director of Life Sciences: otorres@latinalliance.co