This is an archived version. Please see the current version here: E. ADMINISTRATIVE CHANGES
A.1 Change in the name and/or address of the marketing authorisation holder
A.2 Change in the (invented) name of the medicinal product
A.3 Change in name of the active substance or of an excipient
#a1
| A.1 Change in the name and/or address of the marketing authorisation holder | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1, 2 | IAIN | |
| Conditions | |||
| 1. The marketing authorisation holder must remain the same legal entity. | |||
| Documentation | |||
| 1. A formal document from a relevant official body (e.g. Chamber of Commerce) in which the new name or new address is mentioned. | |||
| 2. Revised product information. | |||
#a2
| A.2 Change in the (invented) name of the medicinal product | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| a) for Centrally Authorised products | 1 | 1, 2 | IAIN |
| b) for Nationally Authorised Products | 2 | IB | |
| Conditions | |||
| 1. The check by the EMA on the acceptability of the new name has been finalised and was positive. | |||
| Documentation | |||
| 1. Copy of the EMA letter of acceptance of the new (invented) name. | |||
| 2. Revised product information. | |||
#a3
| A.3 Change in name of the active substance or of an excipient | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1, 2 | 1, 2 | IAIN | |
| Conditions | |||
| 1. The active substance/excipient must remain the same. | |||
| 2. For veterinary medicinal products for food-producing species, the new name has been published in Regulation (EEC) N° 470/2009 before implementation of this change. | |||
| Documentation | |||
| 1. Proof of acceptance by WHO or copy of the INN list. If applicable, proof that the change is in line with the Ph. Eur. For herbal medicinal product, declaration that the name is in accordance with the Note for Guidance on Quality of Herbal Medicinal Products, and with the guideline on declaration of herbal substances and herbal preparations in (traditional) herbal medicinal products. | |||
| 2. Revised product information | |||
#a4
| A.4 Change in the name and/or address of: a manufacturer (including where relevant quality control testing sites); or an ASMF holder; or a supplier of the active substance, starting material, reagent or intermediate used in the manufacture of the active substance (where specified in the technical dossier) where no Ph. Eur. Certificate of Suitability is part of the approved dossier; or a manufacturer of a novel excipient (where specified in the technical dossier) | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1, 2, 3 | IA | |
| Conditions | |||
| 1. The manufacturing site and all manufacturing operations must remain the same. | |||
| Documentation | |||
| 1. A formal document from a relevant official body (e.g. Chamber of Commerce) in which the new name and/or address is mentioned. | |||
| 2. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate). | |||
| 3. In case of change in the name of the holder of the Active Substance Master File holder, updated “letter of access”. | |||
#a5
| A.5 Change in the name and/or address of a manufacturer/importer of the finished product (including batch release or quality control testing sites) | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| a) The activities for which the manufacturer/importer is responsible include batch release | 1 | 1, 2 | IAIN |
| b) The activities for which the manufacturer/importer is responsible do not include batch release | 1 | 1, 2 | IA |
| Conditions | |||
| 1. The manufacturing site undergoing the name and/or address change and all manufacturing operations must remain the same. | |||
| Documentation | |||
| 1. Copy of the modified manufacturing authorisation, if available; or a formal document from a relevant official body (e.g. Chamber of Commerce, or if not available, from a Regulatory Agency) in which the new name and/or address is mentioned. | |||
| 2. If applicable, amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including revised product information as appropriate. | |||
#a6
| A.6 Change in ATC Code / ATC Vet Code | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1 | 1, 2 | IA | |
| Conditions | |||
| 1. Change following granting of or amendment to ATC Code by WHO / ATC Vet Code. | |||
| Documentation | |||
| 1. Proof of acceptance (by WHO) or copy of the ATC (Vet) Code list. | |||
| 2. Revised product information | |||
#a7
| A.7 Deletion of manufacturing sites for an active substance, intermediate or finished product, packaging site, manufacturer responsible for batch release, site where batch control takes place, or supplier of a starting material, reagent or excipient (when mentioned in the dossier)* | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| 1, 2 | 1, 2 | IA | |
| Conditions | |||
| 1. There should at least remain one site/manufacturer, as previously authorised, performing the same function as the one(s) concerned by the deletion. Where applicable at least one manufacturer responsible for batch release that is able to certify the product testing for the purpose of batch release within the EU/EEA remains in the EU/EEA. | |||
| 2. The deletion should not be due to critical deficiencies concerning manufacturing. | |||
| Documentation | |||
| 1. The variation application form should clearly outline the “present” and “proposed” manufacturers as listed in section 2.5 of the application form for marketing authorisations. | |||
| 2. Amendment of the relevant section(s) of the dossier (presented in the EU-CTD format or NTA volume 6B format for veterinary products, as appropriate), including revised product information as appropriate. | |||
| *Note: Where notice has been given by the authorities of the intention to perform an inspection, the deletion of the relevant site shall be notified immediately. | |||
#a8
| A.8 Changes to date of the audit to verify GMP compliance of the manufacturer of the active substance* | Conditions to be fulfilled | Documentation to be supplied | Procedure type |
| IA | |||
| Documentation | |||
| 1. Written confirmation from the manufacturer of the finish product stating verification of compliance of the manufacturer of the active substance with principles and guidelines of good manufacturing practices. | |||
| *Note: This variation does not apply when the information has been otherwise transmitted to the authorities (e.g. through the so-called “QP declaration”). | |||