E. ADMINISTRATIVE CHANGES

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Valid Version — C/2025/5045 (effective 16.01.2026)

Previous version is available here: Variations Guidelines 2013/C 223/01

E.1 Change in the (invented) name of the finished product

E.2 Change in name of the active substance, excipient, medical device (part), or packaging component

E.3 Change in ATC Code

E.4 Change in the name and/or address of the marketing authorisation holder, ASMF holder, storage site of the master and/or working cell bank, manufacturing site for an active substance, intermediate or finished product, primary and/or secondary packaging site, manufacturer responsible for batch release, site where quality control takes place, and/or supplier of a packaging component, medical device (part), starting material, reagent and/or excipient (when mentioned in the dossier)

E.5 Deletion of manufacturing sites for an active substance, intermediate or finished product, storage of master and/or working cell bank, primary and/or secondary packaging site, manufacturer responsible for batch release, site where quality control takes place, and/or supplier of a packaging component, medical device (part), starting material, reagent and/or excipient (when mentioned in the dossier)

#e1

E.1 Change in the (invented) name of the finished product	Conditions to be fulfilled	Documentation to be supplied	Procedure type
(a) for centrally authorised medicinal products	1	1, 2	IA_IN
(b) for nationally authorised medicinal 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. 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.

#e2

E.2 Change in name of the active substance, excipient, medical device (part), or packaging component	Conditions to be fulfilled	Documentation to be supplied	Procedure type
	1	1, 2, 3	IA_IN
Conditions
1. The active substance/excipient/medical device/packaging component must remain unchanged.
Documentation
1. For active substance and excipients, 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 guideline on declaration of herbal substances and herbal preparations in (traditional) herbal medicinal products. For medical devices, updated CE certificate and/or declaration of conformity, if available.
2. Revised product information, as appropriate.
3. Amendment of the relevant section(s) of the dossier.

#e3

E.3 Change in ATC 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.
Documentation
1. Proof of acceptance (by WHO) or copy of the ATC Code list.
2. Revised product information.

#e4

E.4 Change in the name and/or address of the marketing authorisation holder, ASMF holder, storage site of the master and/or working cell bank, manufacturing site for an active substance, intermediate or finished product, primary and/or secondary packaging site, manufacturer responsible for batch release, site where quality control takes place, and/or supplier of a packaging component, medical device (part), starting material, reagent and/or excipient (when mentioned in the dossier)	Conditions to be fulfilled	Documentation to be supplied	Procedure type
a) The change in the name and/or address concerns the marketing authorisation holder	2	1, 2	IA_IN
b) The change in the name and/or address concerns a manufacturer(s)whose activities include batch release of the finished product	1	1, 2	IA_IN
c) The change in the name and/or address does not concern a manufacturer(s) whose activities include batch release of the finished product nor the marketing authorisation holder	1	1, 2, 3	IA
Conditions
1. The physical location of the concerned manufacturing site and all manufacturing operations must remain the same.
2. 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, or if not available, from a competent authority) in which the new name and/or address is mentioned, or a copy of the modified manufacturing authorisation, if available.
2. Amendment of the relevant section(s) of the dossier, including revised product information as appropriate.
3. In case of change in the name of the holder of the Active Substance Master File, updated ‘letter of access’.

#e5

E.5 Deletion of manufacturing sites for an active substance, intermediate or finished product, storage of master and/or working cell bank, primary and/or secondary packaging site, manufacturer responsible for batch release, site where quality control takes place, and/or supplier of a packaging component, medical device (part), starting material, reagent and/or excipient (when mentioned in the dossier)	Conditions to be fulfilled	Documentation to be supplied	Procedure type
	1, 2	1	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. Amendment of the relevant section(s) of the dossier, including revised product information as appropriate.

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