A Path to Prosperity New Directions for African Livestock

1 a Regional Committee for Veterinary Medicinal
Products (CRMV)
The CRMV meets on an ad hoc basis to review
registration dossiers. The committee comprises
scientists recruited for their personal
competence. It is supported by a Permanent
Secretariat, housed at the UEMOA headquarters.
The CRMV is backed up by UEMOA regulations
that define the minimum requirements that
must be applied by member countries for the
production, importation, quality control and
operation of veterinary pharmaceutical
establishments, plus the marketing and
distribution of veterinary medicinal products
in the UEMOA region.
2 a Veterinary Committee of CVOs
The committee’s duties are broader than drug
legislation. It also handles areas of livestock
production where a regional approach shows
clear benefits eg. animal health, safety of
foodstuffs of animal origin, veterinary practice
and animal welfare.
3 a network of laboratories to carry out
quality testing
Nine laboratories were selected, six to analyse
pharmaceutical products and three to analyse
immunological products.
The WAEMU institutions and appropriate legislation
are now in place and monitoring of their operational
capacity by the veterinary committee, neighbouring
regions and the pharmaceutical industry will no
doubt yield important lessons.
Harmonisation of Registration
of Veterinary Medicines in Europe
The regulation of veterinary medicinal products
within the European Union is based on harmonised
legislation established at European Community
level. This legislative framework covers the
manufacture, authorisation (registration), placing
on the market and subsequent monitoring and
maintenance of products.
For over 20 years, a network of three key bodies
has regulated medicines. These are the national
regulatory authorities of the 27 member states,
the European Medicines Agency (EMEA) based in
London and the European Commission in Brussels.
The harmonised system has several benefits:
1 significant reduction in the time and resources
required to obtain and maintain registration
(in multiple countries);
2 a “level playing field,” in terms of the application
of harmonised requirements throughout the
network;
3 improved predictability of both timescales and
requirements for authorisation.
Three fundamental principles are required for this
network or any other region-wide system to operate
successfully:
1 Subsidiarity in terms of pooling legal powers –
which means that the central authority (the
European Commission) should only perform
those tasks which cannot be performed
effectively at national level. This allows national
differences to be accommodated.
2 A robust system of mutual recognition to prevent
duplication of work and maximise the use of
scarce resources (for example if a product is
registered in one country and the product owner
wishes to register it in a second country).
The owner applies for mutual recognition of the
existing registration by the competent authority
of that second country. It is not permissible to
apply for separate registration for the same
product in more than one member state. If the
second state does not recognise registration
then there is a time-limited appeals process.
Alternatively, the product owner may wish to
seek a single authorisation issued by the
European Commission, as this is valid in all
Member States.
3 Mutual trust and transparency is essential if
the network is to function rather than merely
exist on paper.
In addition to these fundamentals a region requires
the physical and human infrastructure to support
the network in terms of places to meet, a permanent
secretariat to coordinate and ensure the continuity
and quality of the work performed, preferably a
common language and an effective IT system.
Finally you need a common interest in work sharing,
pooling of resources and sovereignty in the interests
of each and every member of the network.
From Mackay D. OIE Conference on veterinary
medicinal products in Africa, 2008 147 .
The Impetus Strategy Paper I Page 64