Product Management Service (PMS) - Implementation of ...

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, 2021. Reproduction is authorised provided the source is acknowledged. 24 June 2021 EMA/285848/2020 Information Management Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Chapter 2: Data elements for the electronic submission of information on medicinal products for human use Version Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe EMA/285848/2020 Page 2/213 Table of contents Glossary.

2 8 Scope of this guidance .. 10 Medicinal products in scope .. 10 Submission of medicinal products authorised in EEA countries outside the EU .. 11 Submission of medicinal products authorised under mutual recognition or decentralised procedure in Liechtenstein .. 11 Marketing authorisations granted by the Swiss authorities and recognised by Liechtenstein .. 11 Submission of medicinal Product data using FHIR .. 12 Identifiers and defining characteristics of a medicinal Product entry in PMS .. 13 Product Management Service Identifier (PMS ID) .. 13 Medicinal Product Identifier (MPID).

3 15 Packaged Medicinal Product Identifier (PCID) .. 17 Relationship between PMS ID and ISO standard ISO 11615 Medicinal Product Identifier (MPID) and Packaged Medicinal Product Identifier (PCID) .. 17 Imatinib Company A 25 mg tablets .. 19 Imatinib company A 50 mg tablets .. 20 Access to identifiers .. 21 User guidance .. 22 Provenance .. 26 1. Medicinal Product .. 30 Product Management Service Identifier (PMS ID) .. 30 Medicinal Product Identifier (MPID) .. 31 Domain .. 32 Type .. 32 (Authorised) pharmaceutical form .. 33 Combined pharmaceutical dose form .. 34 Legal status of supply.

4 35 Additional monitoring indicator .. 36 Orphan designation .. 38 Regulatory authorisation type .. 39 Orphan designation status .. 39 Orphan designation number .. 40 Orphan designation status date .. 40 Market exclusivity start date .. 41 Paediatric use indicator .. 42 Full indication text .. 43 Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe EMA/285848/2020 Page 3/213 Language .. 44 EURD ID .. 45 Product classification .. 46 xEVMPD Product type information.

5 46 Legal basis .. 47 ATC code(s) .. 48 Medicinal Product category .. 49 Genetically Modified Organisms (GMOs) .. 50 Medicinal Product name .. 50 Full name .. 52 Country/Language .. 52 (Medicinal Product name) name part(s) .. 55 (Pharmacovigilance) master file .. 66 File type .. 67 File code .. 67 Contact (QPPV) .. 69 Identifier .. 70 Role .. 71 Pharmacovigilance enquiry information .. 72 Email address .. 72 Phone number .. 73 Role .. 74 Attached document .. 74 Master (Attached document) Identifier .. 78 Alternative (Attached document) Identifier.

6 80 (Attached document) Type .. 81 (Attached document) Effective Date .. 82 (Attached document) Language .. 82 Product cross-reference .. 83 Product cross-reference type .. 84 Product cross-reference resource identifier .. 85 Manufacturing business operation .. 85 Manufacturer .. 86 Operation type .. 87 Manufacturing operation start date .. 88 Manufacturing operation end date .. 88 Confidentiality indicator .. 89 Manufacturing authorisation reference number .. 90 Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe EMA/285848/2020 Page 4/213 Effective date.

7 91 (Manufacturing business operation) Medicines Regulatory Agency Organisation .. 92 2. Marketing authorisation information .. 94 Regulatory authorisation type .. 95 Marketing authorisation number .. 95 Country .. 97 Authorisation status .. 98 Authorisation status date .. 99 Date of first authorisation .. 99 International birth date .. 101 Marketing authorisation holder (organisation) .. 105 (Marketing authorisation) Regulator .. 106 Marketing authorisation procedure .. 107 Procedure Identifier .. 107 Procedure type Medicines approval system .. 109 Procedure start date.

8 110 Procedure end date .. 110 Regulatory application .. 111 3. Therapeutic ( Product ) indication .. 115 Indication as "Disease/Symptom/Procedure" .. 115 Co-morbidity .. 116 Intended effect .. 118 4. Packaged medicinal Product .. 121 Packaged Medicinal Product Identifier (PCID) .. 124 Package description .. 125 Language .. 126 Pack size .. 126 Legal status of supply .. 128 Marketing status .. 129 Country .. 129 Marketing status .. 130 (Marketing status) start date .. 131 (Marketing status) end date .. 131 Risk of supply shortage .. 132 Risk of supply shortage comment.

9 133 Status reasons .. 133 Marketing authorisation (Package level) .. 135 Product Management Service (PMS) - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe EMA/285848/2020 Page 5/213 Regulatory authorisation type .. 136 Marketing authorisation number (Package level) .. 136 Country .. 137 Authorisation status .. 138 Authorisation status date (Package level) .. 138 Package item (container) .. 139 Package item (container) type .. 141 Package item reference(s) .. 142 Manufactured item reference(s).

10 143 Device reference(s) .. 143 Package item (container) quantity .. 144 Data carrier identifier .. 145 Material .. 146 Package (component) .. 147 Component type .. 148 Component material .. 148 Device .. 149 Type of combination Product - Drug/ Device; Biological/Device .. 150 Device type .. 151 Device identifier .. 151 Device trade name .. 152 Device quantity .. 153 Manufactured item .. 153 Unit of presentation .. 154 Manufactured item quantity .. 155 Manufactured dose form .. 156 Ingredient .. 157 Manufactured item description .. 158 Shelf life / Storage.