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Manuel Bernet publishes new edition of the Commercial Code

20 Oct 2020

Manuel Bernet, lawyer of Jara Del Favero and professor of Commercial Law at the Universidad de los Andes, published a new edition of the Commercial Code by the prestigious publishing house Tirant lo blanch. This edition has a new feature: each article of the Commercial Code has a heading, which makes it easier to understand, […]

The Law Today

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ISP establishes requirements for the notification and execution of pharmaceutical product recalls

23 Oct 2020

On October 6, 2020, an excerpt of Exempt Resolution No. 3853/2020 of the Institute of Public Health (ISP) was published in the Official Gazette, establishing requirements for the notification and execution of market withdrawal activities for the holders of health registrations and participants in the distribution chain of pharmaceutical products, whether they are voluntary withdrawals or withdrawals instructed by the ISP.

For these purposes, withdrawal activities are classified as Class 1, Class 2 and Class 3, according to the potential health risk that the product involved may represent.

Bearing in mind the above, pharmaceutical product recall activities shall be governed by the following rules:

A. The beginning of the withdrawal shall be notified by electronic means, in the following opportunities:
Once the suspicion or verification of failure or deviation of quality is known, or since the cancellation of the sanitary records, within a maximum period of 24 hours.
Within a period not exceeding 48 hours, accompanying the written records of the notification to each one of the establishments of the distribution chain.

B. In the case of Class 1 withdrawals, the owner of the records shall have the obligation to send a warning message to consumers informing them of the dangers or harmfulness of the lots of the product subject to withdrawal.

C. Obligations are determined for the establishment that has received one or more lots subject to withdrawal shall, establishing standards according to whether it has made previous distribution or not.

D. The holder of the sanitary registration shall submit to the PSI the follow-up reports of the withdrawal from the market and, once the withdrawal is finished, shall submit a conclusive report.

E. The destruction of the medicines shall be the responsibility of the holder of the health registration, according to the regulations in force.

Labor Department issues ruling on the right of workers to vote in the referendum of October 25, 2020

On 19 October 2020, Resolution No. 2760/025 was issued by the Directorate of Labor, concerning the referendum of 25th October, in which it pronounces on the permits that must be granted to workers to participate in the referendum voting In general terms, this opinion includes the following:

Sunday, October 25, 2020 is a mandatory holiday for workers who provide services in shopping centers or commercial complexes managed by the same company name or legal personality; consequently, such employees are free to provide services during that day.

On the other hand, workers who are not included in the previous situation and who are legally exempted from Sunday rest and holidays, and therefore have to provide services on Sunday October 25, are entitled to be absent from their work for a period of 2 hours to attend to cast their vote, without this implying a reduction in their wages. Likewise, they have the right to be granted the necessary permits to carry out the functions of member of the polling station, member of the Vote Counting Association or delegate of the Board of Elections.