On May 7, 2020, Decree No. 58/2019 was published, which modifies the Regulation of pharmacies, drugstores, pharmaceutical warehouses, medicine cabinets and authorized warehouses, regarding electronic commerce of medicines. In particular, it introduces a new Title VI BIS in the Regulation, to regulate the sale of medicines by electronic means, establishing the following rules:
- Pharmacies and pharmaceutical warehouses are empowered to dispense drugs by electronic means, for which a marketing authorization will be required to be issued by the Institute of Public Health (ISP).
- The requirements to obtain authorization are the following:
I. Have authorization for installation or operation, depending on the type of establishment;
II. Have an electronic site, whatever the title, that supports the comercializacion of medicines; and
III. Have a delivery service, owned by the establishment or a third party, provided that it meets the conditions for the maintenance of pharmaceutical products.
- Electronic medicine dispensing establishments must have permanent availability of the products contained in the Pharmaceutical Request regulated in article 101 of the Sanitary Code.
- The sale is regulated, according to the condition of sale of the drug:
I. Direct sale. The establishments will be authorized to sell this type of medication, without requiring a prescription.
II. Simple prescription. The sale of this type of medication will be carried out, after communicating the prescription to the respective establishment, which may be an electronic medical prescription or a digital copy of a physical prescription. In both cases, prescriptions must comply with the requirements of article 101 of the Sanitary Code, and in the case of the digitized copy, the establishment that sells, must also verify the correspondence between the physical support and the digitized document.
III. Retained prescription. The dispensing can be done through an electronic prescription or a digitalized copy of a physical prescription. Regarding the digitized copy, the physical prescription must be delivered upon receipt of the drug by the consumer.
IV. Cheque prescription. Medicines that have this condition of sale may not be sold electronically.
- In the case of drugs that must demonstrate bioequivalence, the website must offer the bioequivalent alternatives available for the product, before the purchase of the drug ends.
- Regarding the dispatch of pharmaceutical products, the following is provided:
I. The dispatch package must adequately protect the product, be sealed, and contain the details of the consumer and his address, the contact details of the retail establishment and the special conditions required for the transportation of the product.
II. It must be ensured that transport does not affect the quality of the product.
III. Third parties may carry the transport of medications. However, the sanitary responsibility will correspond to the authorized retail establishment.
- The establishments for the electronic sale of medicines must make available the conditions for the return of products, in accordance with Law No. 19,496, which establishes regulations on the protection of consumer rights.
- Regulates the information that must be provided by the establishment, regarding prices, pharmaceutical products in particular, general pharmaceutical information and current regulations.
Additionally, it establishes the obligation of electronic retail establishments to inform the Ministry of Health of the prices of pharmaceutical products that are sold, as well as any changes that may occur in them and the discounts offered to consumers. A resolution of this Ministry will regulate the method in which this information will be delivered.
This Decree will be in force from the date of its publication, with the exception of the obligation indicated in the previous paragraph, which will take effect once the resolution indicates it is issued.