EU Implementation Guide (Vet EU IG) on veterinary ...

1 Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged. 20 May 2022 EMA/444352/2021 veterinary Medicines Division EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product database Implementation of the requirements of Regulation (EU) 2019/6 for the Union database on veterinary medicinal products in the European Economic Area Chapter 2: Format for the electronic submission of veterinary medicinal product information Version EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product database EMA/444352/2021 Page 2/83 Table of contents Changes made compared to version.

2 5 Glossary .. 7 Scope of this guidance .. 8 veterinary medicinal products in scope of the UPD .. 8 Identification of a veterinary medicinal product in the UPD .. 9 UPD ID Level 1: the Product identifier .. 9 UPD ID Level 2: the Permanent Identifier .. 10 UPD ID Level 3: the Package Identifier .. 11 Confidentiality .. 12 User Guide .. 13 References to FHIR versions .. 14 1. veterinary medicinal product .. 15 Domain .. 15 Product Record Status .. 16 Product identifier .. 16 Permanent identifier .. 17 (Authorised) pharmaceutical form .. 17 Legal status of supply .. 18 Product classification .. 19 (Marketing authorisation application) Legal basis .. 20 ATCvet code(s) .. 20 ATC vet code(s) flag.

3 21 veterinary medicinal product name .. 22 veterinary medicinal product name .. 23 Name part .. 23 Country/Language .. 24 (Pharmacovigilance System) Master file (PSMF) .. 26 (PSM) File status .. 26 (PSM) File type .. 26 (PSM) File code .. 27 (PSM) File location .. 27 Pharmacovigilance Contact (QPPV) .. 27 QPPV name .. 28 QPPV Role .. 28 QPPV Location .. 29 Attached document .. 29 (Attached document) identifier .. 30 (Attached document) status .. 30 (Attached document) type .. 31 (Attached document) country .. 31 (Attached document) content type .. 32 (Attached document) language .. 32 EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product database EMA/444352/2021 Page 3/83 (Attached document) content.

4 33 (Attached document) title .. 33 (Attached document) related veterinary medicinal 34 Product cross-reference .. 34 Product cross-reference type .. 35 Reference product identifier .. 36 Source product identifier .. 37 Manufacturing Business Operation .. 37 Manufacturer .. 38 Manufacturing activity .. 38 Product version number .. 39 2. Authorisation/registration/entitlement information .. 39 Authorisation/registration/entitlement type .. 41 Authorisation/registration/entitlement number .. 42 Country .. 43 Responsible authority (organisation) .. 43 Authorisation status .. 44 Date of authorisation status change .. 44 Marketing authorisation date .. 45 Product owner (organisation).

5 45 Source wholesale distributor (organisation) .. 45 Destination wholesale distributor (organisation) .. 46 Reference member state .. 46 Concerned Member States .. 47 Marketing authorisation procedure .. 47 Procedure number .. 47 Procedure type .. 49 3. Pharmaceutical product .. 50 Ingredient .. 50 Route of 50 Target species .. 51 Withdrawal period .. 51 Tissue .. 52 Period .. 52 Note .. 53 Administrable dose form .. 54 4. Ingredient .. 54 Ingredient role .. 55 Manufacturer .. 55 Substance .. 55 Substance .. 56 Strength (quantitative composition) .. 56 Reference strength .. 60 EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product database EMA/444352/2021 Page 4/83 5.

6 Packaged medicinal product .. 63 Package description .. 64 Language .. 66 Pack size .. 66 Package 67 Legal status for the supply (package level) .. 67 Marketing authorisation (package level) .. 68 Marketing authorisation number (package Level) .. 68 Manufactured item .. 69 Unit of presentation .. 70 Manufactured item quantity .. 70 Manufactured dose form .. 71 Ingredient .. 73 Availability status .. 74 Country .. 74 Availability 74 Availability status date .. 75 Annex 1: Common/European and national data set .. 77 Annex 2: Product information documents requirements .. 80 EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product database EMA/444352/2021 Page 5/83 Changes made compared to version Section Heading Change applied Name type Clarification added related to the fact that Name type 'Full name' should not be used, and therefore not selected, from the Medicinal Product Name Part Type RMS list (PSM) File code Clarification added on the format that PSMF code should follow.

7 The format advisable is the following: prefix PSMF followed by the reference number of the MAH/QPPV s choice: PSMFXXXXXXX. (Attached document) type Clarification added on the values to be used and the relevant identifiers to be used for each value. (Attached document) country Clarification added for CAPs. (Attached document) title Clarification added on the rules concerning the naming convention to be used in UPD documents: The use of spaces within the name of a document (title) is not allowed. Product version number New section has been added to reflect the addition of the field version number. Marketing authorisation date In order to align the guidance on the Vet EU IG with the current Implementation , the value attribute of the system node has been updated from to.

8 Source wholesale distributor (organisation) Repeatability condition changed from NO to YES, allowing in this way that more than one source wholesale distributor is assigned to a product entry. Withdrawal period Clarification added: an example was added as follows: There are also cases where you can use the commodity/tissue in question immediately after the use of the product, in such case, the withdrawal period is actually zero days. Annex 1 Product Owner becomes European & national Clarification added in the annex. Note: for the data field Product record status, Procedure type and Product Owner the RMS will provide the value at the time of creation, and subsequent updates will be made by the CMS.

9 EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product database EMA/444352/2021 Page 6/83 Section Heading Change applied Annex 2 Product information documents requirements Annex 2 added. EU Implementation Guide (Vet EU IG) on veterinary medicines product data in the Union Product database EMA/444352/2021 Page 7/83 Glossary ATC vet code: veterinary Anatomical Therapeutic Chemical code CA: Competent authority CAP: Centrally authorised product Class: A group of related data attributes CP: Centralised procedure DCP: Decentralised procedure eAF: electronic Application Form EC: European Commission EEA: European Economic Area EMA: European Medicines Agency EU: European Union FHIR: Fast Healthcare Interoperability Resources GMP: Good manufacturing practice ID: Identifier IG: Implementation Guide IS/LI/NO: Iceland, Liechtenstein, Norway ISO.

10 International Organization for Standardization LOC ID: Location Identifier MA: Marketing Authorisation MAA: Marketing Authorisation Application MAH: Marketing Authorisation Holder MRP: Mutual recognition procedure NAP: Nationally Authorised Product NCA: National competent authority NP: National procedure OMS: Organisations Management Service ORG ID: Organisation identifier Package ID: Packaged Medicinal Product Identifier PL: Package leaflet PMS: Product Management Services PSMF: Pharmacovigilance system master file QPPV: Qualified person responsible for pharmacovigilance RMS: Reference Member State RMS: Referentials Management Services SRP: Subsequent Recognition Procedure SMS: Substance Management Service SPC: Summary of Product Characteristics SPOR: Substances Products Organisations Referentials UPD: Union Product database Vet EU IG.