Search for:
Category

Product Regulation & Liability

Category
In ESG

Spain: New changes to the Code of Good Practice for the pharmaceutical industry

by 2 Mins Read

The Spanish association of pharmaceutical companies (“Farmaindustria”) has updated the Code of Good Practice for the Pharmaceutical Industry (“Code”), which came into force last 1 January 2021. This amendment is mainly aimed to introduce to section 14.2 of the Code a new definition and regulation for non-interventional studies in accordance with the provisions of the new Royal Decree 957/2020, of 3 November, which regulates non-interventional studies with medicines for human use (“RD 957/2020”). The RD 957/2020 came into force last 2 January 2021.

Read More
In Europe

United Kingdom: Veterinary Medicines Directorate guidance on the regulation of animal health products in the UK post-Brexit

by 2 Mins Read

With the changes to the regulation of veterinary medicines in the UK as a result of Brexit, the Veterinary Medicines Directorate has created a helpful information hub pulling together its communications on current and future regulatory changes. Access the Hub here, including useful explainers on “Application and authorisation“, “Manufacturing and distribution“, and “Pharmacovigilance“, and see below for a summary of some key points.

In Argentina

Argentina: Creation of the “Liquefied Natural Gas (“LNG”) Operators Registry”

by and 3 Mins Read

Through Resolution No. 706/2021, published on July 27 2021 and in effect as from that day, the Secretary of Energy created the “Liquefied Natural Gas Operators Registry” within the scope of the Undersecretariat of Hydrocarbons, dependent on the Secretary and the Ministry of Economy. The Resolution also regulated the requirements for granting LNG export permits for up to 20 years.

Read More
In Asia-Pacific

Singapore: HSA publishes draft guidelines on the classification of Standalone Medical Mobile Applications and Qualification of Clinical Decision Support Software

by and 2 Mins Read

On 19 July 2021, the Medical Devices Branch (MDB) of the Health Sciences Authority (HSA) published its draft “Regulatory Guidelines on Risk Classification of Standalone Medical Mobile Applications (SaMD) and Qualification of Clinical Decision Support Software (CDSS)” for comments.

In Africa

South Africa: Regulation of payment services for card transactions

by and 4 Mins Read

The South African Reserve Bank has recently issued a directive concerning issuing and acquiring domestic card transactions. The Directive introduces regulations for all card issuers, card acquirers and domestic merchants regarding card issuing, acquiring and acceptance services for domestic card transactions. The Directive aims to ensure that the provision of domestic card payment services does not endanger the National Payment System, and for this reason, the SARB requires domestic card issuers to be domestic clearing system participants and requires that domestic merchants use local card acquirers.

Read More
In Asia-Pacific

Singapore: Health Sciences Authority trials bot to crack down on contraband products sold online

by and 2 Mins Read

The Singapore Health Sciences Authority is trialing an e-commerce surveillance tool to crack down on contraband products sold online, including illegal drugs, health products and cosmetics. The bot uses robotic process automation and artificial intelligence to trawl through online listings. It analyses information from the listings, including pictures, descriptions and profiles, to identify illegal products and listings that contain illegal or dangerous ingredients.

In Europe

Poland: New draft amendment to the Reimbursement Law

by 4 Mins Read

On 30 June 2021, the largest amendment to the Act of 12 May 2011 on Reimbursement of Medicinal Products, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices (“Reimbursement Law”) was published for public consultations until the end of August (“Draft”). The Draft is intended to enter into force within three months of its publication; however, it is difficult to predict how long the legislation process will last.

Read More
Load More