02 Jun 2020
A new member of staff has joined Jara Del Favero Lawyers, as of June 1, 2020. Macarena Naranjo Opazo, who studied law at the Pontifical Catholic University of Valparaíso, Macarena will be part of the Corporate and Competition areas in JDF. Macarena Naranjo previously worked at the Office of the Superintendent of Education, where she […]
05 May 2020
The recent incorporation of Alvaro Caviedes as a partner, and Christian Schiessler will allow deepening legal advice in these practice areas, in which both professionals have recognized experience and specialization. New and important changes were recently made in the law firm Jara Del Favero (JDF Abogados), which will make it possible to strongly promote legal […]
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The National Aquaculture registry and the relevance of entering the environmental impact assessment system
07 May 2020
On April 23, 2020, the National Comptroller of the Republic (“CGR”) addressed, the National Fisheries and Aquaculture Service (“SERNAPESCA”), inquiring if it is appropriate to require, holders of aquaculture projects which do not need an aquaculture concession or authorization, prior to its registration in the National Registry of Aquaculture (“RNA”), to present the response to the query regarding the relevance of entry to the Environmental Impact Assessment System (“SEIA”), of its respective project, so that this inscription is valid and unequivocal.
SERNAPESCA states that this entity does not require, as a prerequisite and / or enabler, the letter of relevance or consultation on entry to the SEIA for the respective sectoral permits which grant and understand that such request has been delivered as a request of the titular person.
In its report, the Environmental Assessment Service (“SEA”), once again states that it is not appropriate to subordinate the granting of a sector authorization to the response of a query of relevance to enter the SEIA, since the resolution that is pronounced on a pertinent consultation does not provide certainty that the project in question can be carried out without previously submitting to the procedure, since may vary due to new backgrounds or conclusions of the Environment Superintendence ( “SMA”), standards with which the latter agrees.
CGR concludes that of the applicable regulations (General Law of Fishing and Aquaculture, Regulation of Concessions and Authorizations of Aquaculture, Regulation of Registration in the RNA), the consultation of relevance or its response is not a legal or regulatory requirement provided by the legal system for the purposes of registration in the RNA of those projects indicated, but constitutes a voluntary process, which allows the holders, of those to contact the Executive Director and regional directors of the SEA, as appropriate, in order to request an opinion, based on the background provided for this purpose if a project or activity, or its modification, must be submitted to the SEIA (criteria contained in opinions 7,620, 2013 and 25,269, 2014 apply).
Therefore, the pronouncement issued by the SEA is framed within the statements of judgment completed by the Administration in the exercise of their powers, by means of how they express their point of view on the matter on which an opinion has been requested, without such an instrument being binding since its response does not preclude from subsequently modifying it in the event that the accompanying documents do not conform to reality (criteria applies, contained in opinions 7,620, of 2013 and 463 of 2015).
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.