- Latest available (Revised)
- Original (As made)
There are multiple versions of this provision on screen. These apply to different geographical extents.
The term provision is used to describe a definable element in a piece of legislation that has legislative effect – such as a Part, Chapter or section.
Sometimes the text of a provision is changed, but the change(s) only apply to a particular geographical area. In some limited cases where this happens, the editorial team create a version for each different geographical area. Multiple versions are only created in this way where the change in question is a substitution so that there are different versions of the text for the different extents. Insertions and repeals of text do not give rise to such multiple versions.
There are currently no known outstanding effects for the The Veterinary Medicines Regulations 2013, Paragraph 59.
Revised legislation carried on this site may not be fully up to date. At the current time any known changes or effects made by subsequent legislation have been applied to the text of the legislation you are viewing by the editorial team. Please see ‘Frequently Asked Questions’ for details regarding the timescales for which new effects are identified and recorded on this site.
59.—(1) The marketing authorisation holder must submit to the Secretary of State records of all adverse reactions (including nil reports) in the form of a periodic safety update report for each marketing authorisation in accordance with this paragraph, including a summary of each incident and a list of all the symptoms using internationally recognised veterinary and medical terminology.
(2) A marketing authorisation holder who has not yet placed a product on the market in the United Kingdom must submit a periodic safety update report immediately upon request of the Secretary of State and at least every six months after authorisation.
(3) Following the placing on the market in the United Kingdom, the marketing authorisation holder must submit a periodic safety update report to the Secretary of State immediately upon request and—
(a)at least every six months during the first two years following the initial placing on the market;
(b)once a year for the following two years; and
(c)thereafter, at three-yearly intervals.
(4) Following the granting of a marketing authorisation, the marketing authorisation holder may apply to the Secretary of State to change the periods of notification.
(5) The periodic safety update report must include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product.
(6) The periodic safety update report must include—
(a)the volume of the product sold in each year covered by the report, calculated on an annual basis beginning 1st January;
(b)the number of adverse reactions for each year of the report;
(c)the ratio of adverse reactions to volume of product sold for each year of the report, together with an explanation of the basis of the calculation;
(d)differentiation of data based on—
(i)target species (if the product is authorised for use in more than one species);
(ii)reaction type (such as serious, non-serious, human, suspected lack of efficacy, unauthorised use or other);
(iii)the country of origin of the report.
(7) If the product is indicated for more than one species, the information in sub-paragraph (6)(c) must be based so far as is practicable on the estimated use of the product.
(8) Data relating to different formulations (either different dosage forms or different strengths) must be provided in separate reports.
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
59.—(1) The marketing authorisation holder must submit to the Secretary of State records of all adverse reactions (including nil reports) in the form of a periodic safety update report for each marketing authorisation in accordance with this paragraph, including a summary of each incident and a list of all the symptoms using internationally recognised veterinary and medical terminology.
(2) A marketing authorisation holder who has not yet placed a product on the market in [F3Northern Ireland] must submit a periodic safety update report immediately upon request of the Secretary of State and at least every six months after authorisation.
(3) Following the placing on the market in [F4Northern Ireland], the marketing authorisation holder must submit a periodic safety update report to the Secretary of State immediately upon request and—
(a)at least every six months during the first two years following the initial placing on the market;
(b)once a year for the following two years; and
(c)thereafter, at three-yearly intervals.
(4) Following the granting of a marketing authorisation, the marketing authorisation holder may apply to the Secretary of State to change the periods of notification.
(5) The periodic safety update report must include a scientific evaluation of the risk-benefit balance of the veterinary medicinal product.
(6) The periodic safety update report must include—
(a)the volume of the product sold in each year covered by the report, calculated on an annual basis beginning 1st January;
(b)the number of adverse reactions for each year of the report;
(c)the ratio of adverse reactions to volume of product sold for each year of the report, together with an explanation of the basis of the calculation;
(d)differentiation of data based on—
(i)target species (if the product is authorised for use in more than one species);
(ii)reaction type (such as serious, non-serious, human, suspected lack of efficacy, unauthorised use or other);
(iii)the country of origin of the report.
(7) If the product is indicated for more than one species, the information in sub-paragraph (6)(c) must be based so far as is practicable on the estimated use of the product.
(8) Data relating to different formulations (either different dosage forms or different strengths) must be provided in separate reports.
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F3Words in Sch. 1 para. 59(2) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(j)(iv)
F4Words in Sch. 1 para. 59(3) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(j)(iv)
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download.
Would you like to continue?
The Whole Instrument you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
The Schedules you have selected contains over 200 provisions and might take some time to download. You may also experience some issues with your browser, such as an alert box that a script is taking a long time to run.
Would you like to continue?
Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.
Original (As Enacted or Made): The original version of the legislation as it stood when it was enacted or made. No changes have been applied to the text.
Geographical Extent: Indicates the geographical area that this provision applies to. For further information see ‘Frequently Asked Questions’.
Show Timeline of Changes: See how this legislation has or could change over time. Turning this feature on will show extra navigation options to go to these specific points in time. Return to the latest available version by using the controls above in the What Version box.
Explanatory Memorandum sets out a brief statement of the purpose of a Statutory Instrument and provides information about its policy objective and policy implications. They aim to make the Statutory Instrument accessible to readers who are not legally qualified and accompany any Statutory Instrument or Draft Statutory Instrument laid before Parliament from June 2004 onwards.
Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:
Impact Assessments generally accompany all UK Government interventions of a regulatory nature that affect the private sector, civil society organisations and public services. They apply regardless of whether the regulation originates from a domestic or international source and can accompany primary (Acts etc) and secondary legislation (SIs). An Impact Assessment allows those with an interest in the policy area to understand:
This timeline shows the different points in time where a change occurred. The dates will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. The first date in the timeline will usually be the earliest date when the provision came into force. In some cases the first date is 01/02/1991 (or for Northern Ireland legislation 01/01/2006). This date is our basedate. No versions before this date are available. For further information see the Editorial Practice Guide and Glossary under Help.
Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:
Click 'View More' or select 'More Resources' tab for additional information including: