Quality Policy

Quality Policy of the Institute for State Control of Veterinary Biologicals and Medicines

The Institute for State Control of Veterinary Biologicals and Medicines (ÚSKVBL) applies a quality assurance system to all important processes. An integral part of the quality assurance system is the quality policy announced by the Director of the Institute, which the Institute declares its commitments both to external entities and to its employees.
The aim of the quality policy is to ensure that the ÚSKVBL fulfils its responsibilities under the relevant national and EU legislation. In the field of veterinary medicines, the Institute contributes to the development of veterinary care with regard to the current state of scientific knowledge.

Having regard to the following:

• having regard to the legal framework,
• having regard to the obligations of the Czech Republic under international treaties, including membership of the European Communities and membership of professional organisations,
• having regard to the responsibilities entrusted to the ÚSKVBL and its mission in the field of human, animal and environmental protection,
• having regard to the clients and partners of the Institute,
• having regard to its staff,

the Director announces a quality policy that reflects the consensus of interests of participants in the regulation of veterinary medicines and their residues, veterinary products and veterinary technical devices. 
 
ÚSKVBL

a) ensures, using the relevant legislation and taking into account scientific and technical progress, that veterinary medicinal products whose properties correspond to current scientific and technical requirements for quality, safety and efficacy are authorised for the needs of veterinary practice in the Czech Republic.
The Institute ensures the appropriate professional standard of pre-authorization and post-authorization evaluation of veterinary medicinal products, and provides evaluators of information on veterinary medicinal products with the necessary material and technical background and administrative support.
For this purpose, the Unit for Administrative and Procedural Support is established within the ÚSKVBL - Department of Registration and Approval, which creates the appropriate administrative service for evaluators, and furthermore, with regard to the specificities of individual types of medicinal products, individual units with specialized evaluators are established within the Department of Registration and Approval:

• Quality Assessment for Pharmaceutical VMP,
• Safety and Residues Assessment for Pharmaceutical VMP,
• Efficacy Assessment for Pharmaceutical VMP and clinical trials,
• Q/S/E Assessment for Immunological VMP (with assessors specialised in the evaluation of bacterial vaccines and hyperimmune sera, viral vaccines for poultry and rabbits, viral vaccines for other animal species).

The Unit of Expert Activities related to Marketing Authorisation communicate with each other and cooperate in order to ensure the assessment of products that require a special approach and expertise combining the assessment of pharmaceuticals and immunologicals, such as biological products.
 
b) ensures, using the relevant legislation, that veterinary products are approved for the needs of veterinary practice in the Czech Republic, whose properties correspond to the current scientific requirements on the quality, safety and efficacy of veterinary products. In the case of veterinary products, it also lays down requirements that do not create obstacles to the free movement of goods within the EC free market that would be disproportionate to the protection of the protected interests of the Czech Republic in the context of the protection of human health, animal health or the environment.
For this purpose, the Institute ensures an appropriate professional standard of evaluation of the properties of veterinary products, taking into account the state of marketing in the EU Member States, so that the principles of free movement of goods are not violated.
For this purpose, the Unit for Coordination of VMP Marketing Authorisation Procedures, Regulation of Non-medicinal VP and Veterinary Devices and Administrative Support ensuring the evaluation of the properties of veterinary products and evidence of veterinary technical devices is established within the ÚSKVBL - Department of Registration and Approval.
 
c) ensures, using the relevant legislation, that clinical trials of veterinary medicinal products are authorised and carried out in the territory of the Czech Republic in accordance with the principles of good clinical practice and in compliance with the rules for the protection of animals against cruelty.
For this purpose, the Institute ensures an adequate standard of assessment of applications for clinical trials and carries out inspections to check compliance with good clinical practice in clinical trials conducted.
For this purpose, the Department of Registration and Approval of the Institute of Veterinary Medicines (ÚSKVBL) has established the Unit for Efficacy Assessment for Pharmaceutical VMPs and Clinical Trials Evaluation, which ensures the assessment of applications for clinical trials of veterinary medicinal products and the control of compliance with the conditions for conducting clinical trials, as approved by the Institute (ÚSKVBL).
 
d) ensures, using the relevant legislation, that authorisations for the manufacture of veterinary medicinal products are issued in the Czech Republic, including authorisations for the import of veterinary medicinal products from third countries, certificates for manufacturers of active substances and authorisations for the distribution of veterinary medicinal products and authorisations for the manufacture of veterinary medicinal products only to those persons who meet the current legislative and scientific requirements for good manufacturing practice of veterinary medicinal products, requirements for the manufacture of active substances, requirements for good distribution practice of veterinary medicinal products and requirements for good manufacturing practice of veterinary products, and monitors, through regular and random inspections and controls, the continuous application of the current requirements for individual regulated entities, including measures in the event of the detection of non-conformities in the manufacture or distribution or in the event of the detection of defects in the quality of veterinary medicinal products or veterinary products.
For this purpose, the ÚSKVBL ensures an adequate standard of assessment of applications for authorisation to manufacture veterinary medicinal products, applications for authorisation to manufacture veterinary medicinal products, applications for the issue of certificates of a manufacturer of active substances, applications for authorisation for a control laboratory, applications for authorisation to distribute veterinary medicinal products and ensures an adequate standard of inspection and control of good manufacturing practice, good distribution practice and good manufacturing practice in the manufacture of active substances.
For this purpose, the Unit of Good Manufacturing Practice, the Unit of Good Distribution Practice and the Unit of Medicated Feed and Distribution of Medicinal Substances are established within the ÚSKVBL - Department of Inspection.
 
e) ensures, using the relevant legislation, that proper, systematic and risk-based supervision is applied in the Czech Republic

• the market in veterinary medicinal products, veterinary products and veterinary technical devices, in particular to prevent the placing on the market of unauthorised veterinary medicinal products, veterinary products which have not been authorised, veterinary medicinal products which do not conform to the particulars in the dossier, veterinary products which do not conform to the particulars on the basis of which they were authorised, falsified veterinary medicinal products or veterinary products,
• the dispensing of veterinary medicinal products, in particular that the dispensing is carried out in accordance with the relevant legislation, that the veterinary medicinal products are not dispensed to unauthorised persons, that the dispensing of medicinal products does not adversely affect the quality, safety or efficacy of veterinary medicinal products, and that the dispensing of veterinary medicinal products is properly documented,
• the use of medicinal products in the provision of veterinary care, in particular the use of different types of medicinal products where they can be used to address the problem in animals, the proper documentation of the use of medicinal products and the prevention of misuse of medicinal products,
• handling substances which have an anti-infectious, anti-inflammatory, anti-parasitic, hormonal and psychotropic action and which may be used for the manufacture of veterinary medicinal products.

For this purpose, the Unit of Market Control is established within the ÚSKVBL - Department of Inspection.

f) ensures laboratory control

• veterinary medicines and excipients,
• residues of veterinary medicinal products in raw materials and foodstuffs of animal origin,
• veterinary products.

In the field of VMP residue controls in foodstuffs of animal origin, the Institute acts as a National Reference Laboratory in accordance with the plans for official controls of residues drawn up and updated by the State Veterinary Administration of the Czech Republic.
In the field of laboratory control of veterinary medicines and excipients, the Institute acts as an Official Medicines Control Laboratory.
In the field of veterinary products, the Institute acts as a laboratory for the control of veterinary products.
For this purpose, the ÚSKVBL ensures an adequate standard in the performance of laboratory analyses.
For this purpose, the Official Medicines Control Laboratory and the National Reference Laboratory for Residues of Banned Substances are established within the ÚSKVBL. 
 
g) ensures post-authorisation monitoring of the characteristics of veterinary medicinal products and veterinary pharmacovigilance throughout the scope of veterinary pharmacovigilance as defined by legislation and requirements laid down within the EU or international harmonisation activities (VICH). Thus, in the context of veterinary pharmacovigilance, it continuously monitors the benefit-risk balance of veterinary medicinal products by means of information on:

•  adverse reactions to veterinary medicinal products,
• serious adverse reactions to veterinary medicinal products,
• unexpected adverse reactions to veterinary medicinal products,
• adverse reactions that have occurred in humans in connection with VMP,
•  exceedance of established maximum residue limits for veterinary medicinal products in raw materials and foodstuffs of animal origin,
• adverse effects of VMP on the environment,
• adverse reactions to medicinal products used in non-authorised animals,
• the lack of efficacy of veterinary medicinal products.

In order to fulfil its tasks in the field of veterinary pharmacovigilance, the ÚSKVBL develops an effective system for the collection of information in the field of veterinary pharmacovigilance. For this purpose, a Pharmacovigilance Unit is established within the ÚSKVBL - Department of Inspection. 

h) does not create obstacles to the practical application of veterinary medicines, veterinary products and veterinary technical devices and the introduction of new procedures and technologies through unnecessary requirements and inefficient work.
In practice, the creation of obstacles is mainly due to the lack of speed and expertise in issuing decisions and opinions, processing applications in the field of marketing authorisations, changes, clinical trials, inspection and laboratory activities. It is important to focus on realistic and justified requirements harmonised with international standards and to carry out interventions on a minimum sufficient extend.   
 
i) make the most efficient use of available resources by selecting optimal procedures and taking into account priorities determined by the degree of risk of adverse effects of veterinary medicinal products, veterinary medicinal products and veterinary technical devices on humans, animals or the environment.
As the financial and personnel resources for the regulation of veterinary medicines, veterinary products and veterinary technical devices are limited, it is necessary to focus primarily on the effectiveness of the ÚSKVBL procedures and to monitor, according to established priorities, especially high-risk medicines, veterinary products and veterinary technical devices, as well as situations that may lead to an increase in the risk of damage to human, animal or environmental health. It is necessary to choose such procedures to cope with the problems that will be the least costly while securing the goal. It is also important to prefer preventive activities that detect possible health, economic and environmental damage in a timely manner.
 
j) cooperate with appropriate partners and make use of their professional potential, thereby increasing the efficiency of activities.
Accelerating the agenda, increasing the professional standard and saving resources can be achieved by working with qualified partners, whether it is a partnership with institutions and administrative authorities, professional and professional companies in the Czech Republic or regulatory authorities in other EU countries.
 
k) is fair and accommodating to regulated entities, contributes to creating an environment of trust in the system of regulation of veterinary medicines, veterinary products and veterinary technical devices, and performs activities in a way that contributes to the international integration of the Czech Republic.
A good relationship, understanding of the situation and, where possible, taking into account the needs of regulated entities and other partners will make it possible to better identify the most appropriate and rapid ways of solving individual problems. For this reason, it is useful to work transparently, to be in contact with partners and to monitor their views and trends, to discuss, where possible, pre-planned measures, to provide timely, content- and language-intelligible and professionally and content-sufficient information, to facilitate applicants in resolving their cases and, of course, to guarantee standard access to all regulated entities. The ÚSKVBL publishes sufficient information about the activities of the ÚSKVBL by appropriate means.
 
l) achieves employee satisfaction.
Without satisfied employees, it is not possible to carry out the ‘mission’ of the ÚSKVBL. Therefore, the awareness of employees about the activities of the ÚSKVBL, their involvement in the implementation of the ÚSKVBL policy and emphasising the importance of their work, ensuring continuous education, enabling self-education and adequate financial remuneration cannot be neglected. Through regular evaluation, the ÚSKVBL differentiates employees and enables capable and efficient employees to work appropriately.
 
m) implements all measures to reduce corruption in the ÚSKVBL environment.