PM+: Veterinary medicines need single manufacturing specification
Commission's plans for harmonising veterinary medicine authorisation need review, argues IFAH-Europe's Roxanne Feller.
The European commission's proposal for a regulation for veterinary medicines includes plans to harmonise the product information for groups of similar veterinary medicines.
The objective is to increase the availability of these medicines across Europe and remove some of the administrative hurdles that prevent animal owners accessing the much-needed tools that help keep their animals healthy.
A veterinary medicinal product is not just the liquid in the bottle or the tablet in the blister pack. The 'product' is also all the information that comes with it, including target species and disease, dosage instructions, safety warnings, disposal instructions and, for livestock products, the withdrawal period.
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This approved information is part of the marketing authorisation for a medicine and is defined in the summary of product characteristics (SPC), and is publicly available.
Relatively few veterinary medicines have centralised marketing authorisation in the EU. The vast majority have national marketing authorisations following an assessment of a manufacturer's data package by a national authority.
Differences in the conclusions of the national assessments have led to differences in the national SPCs of the same product of a company, meaning that one medicine from the same company may have different label information in different markets.
This situation creates inexplicable and confusing discrepancies for farmers and veterinarians working in different EU countries, and hampers the single market in general. There are two aspects of the commission's proposal that can be improved.
Firstly, it focusses just on harmonising the SPC, and misses a unique opportunity to harmonise the entire marketing authorisation information of the same product from the same company, where this differs between member states.
Harmonising the marketing authorisation of a product would not only create a single SPC, but would also include the manufacturing quality control data into the harmonisation process, resulting in a single manufacturing specification for the product.
This would deliver on three of the five objectives of the commission, namely, increasing medicines availability (by allowing all label indications in all member states), facilitating the single market and reducing administrative bureaucracy.
Secondly, the commission proposal intends to harmonise the SPC of "groups of similar" products (same active ingredient, same strength and same physical form, such as tablet or solution).
This means that a similar product from two different manufacturers would have to have the same SPC.
This is not a workable proposal, as it is not possible for the SPC from two manufacturers to be exactly the same, mainly due to formulation differences.
It will only be possible to harmonise parts of the SPC, such as the conditions of use (for example dosage instructions and safety warnings).
A more workable proposal would be to include an optional legal mechanism to harmonise the SPCs of the same product of a company, and subsequently to align all versions of it.
The idea of harmonising non-identical products is not scientifically sound. Individual products are supported by individual data packages submitted by individual manufacturers.
A company takes legal responsibility for their product based on the data it has generated and submitted for authorisation.
This essential principle of the marketing authorisation process and legal liability should not be undermined by rewording one company's SPC based on another company's data.
Harmonising the SPCs of 'groups of similar' products would also create a huge amount of work for updating products that are already on the market and may lead to the removal of some products from the market for which the effort cannot be justified.
This goes against the desired goal of streamlining processes to increase availability of veterinary medicines.
This approach can only be justified in those cases where a distinct need and benefit can be demonstrated.
We at IFAH-Europe believe a procedure to harmonise the SPC of the 'same' product, i.e. from a single manufacturer, and all versions of it, across all member states would be more workable for all parties involved.
In addition, the manufacturing quality data of each national marketing authorisation for a product should be harmonised.
This is necessary to create a single EU manufacturing specification. This is very important as it would reduce the cost and complexity of manufacturing the 'same' product and bring complete harmonisation of all aspects of the product, eliminating the confusion for all parties involved – the farmers, the veterinarians, the regulatory authorities, the inspectors and the manufacturers.
Such a progressive and forward-looking system would go a long way to obtaining a genuine EU-wide approach to authorising medicines, which leaves no animals, or indeed even people, behind.
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