Event Details

Consultation Session: Veterinary Medicinal Products

16 September 2016

Following an EU-wide consultation with stakeholders on the revision of the legal framework for veterinary medicinal products, a consultation session was held on Friday, September 16, 2016 with local stakeholders. The session was organised by MEUSAC together with MSDEC.

The new regulations aim to make safer the consumption by animals of medicinal products while also aiming to prevent unlicensed use of such products and to cut down on unlicensed suppliers of veterinary medicinal products to bring about a level playing field.

Mr Stephen Spiteri from the Veterinary and Phytosanitary Regulations Department, MSDEC, gave a presentation on the proposed regulations.

He explained that changes came about after the EU acknowledged that there was a lack of veterinary medicines, a deficient operation of internal market and high administrative burdens, normally associated with medicines consumed by humans, which, when it comes to animals, are unnecessary.

Mr Spiteri outlined a number of problem drivers which led to the new proposed legislation, including language problems on packaging of such products (information on the packaging was not always in the English language), complex post authorisation requirements and a legislation which is not innovative.

He also highlighted that the ‘Sunset Clause’ - a measure that provides that a product will cease to have effect after a specific date, is likely to be removed. Citing an example, he said that vaccines are normally used during epidemics and it was not right for pharmacists or suppliers to have to remove such products once the epidemic is over and the products go to waste as a result due to the fact that the sunset clause authorisation of sale drops.

Mr Spiteri further explained that the new legislation will bring about more clarity on issues such as internet retailing of veterinary medicinals.

Until now, it is not yet clear what products should be allowed to be purchased online.

According to Mr Spiteri, a database will also be set up where licensed suppliers will be included in the database. Those found to be selling medicinal products without ever having been registered in the database will face hefty fines.

Click here to view proposed regulations visit.

 

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