Changes between two versions
What changed between the plenary report and the adopted text
From · plenary report· 21 Mar 2024
on the proposal for a regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulation (EC) No 1394/2007 and Regulation (EU) No 536/2014 and repealing Regulation (EC) No 726/2004, Regulation (EC) No 141/2000 and Regulation (EC) No 1901/2006
To · adopted text· 10 Apr 2024
Union procedures for the authorisation and supervision of medicinal products for human use and rules governing the European Medicines Agency
These two texts have too little in common to compare paragraph by paragraph: they are different documents rather than versions of one (for example one group’s motion and the joint text that was adopted).
+2,047 added · −391 removed · 0 changed paragraphs, packaging included.
Part 40 of 42: Paragraphs 2332–2391
Added:(f) Pharmaceutical form;
Added:(g) Strength(s);
Added:(h) Route(s) of administration;
Added:(i) Affected pack size(s);
Added:(j) Alternative, pharmaceutical form, strength, route of administration or pack size, not affected by the suspension, cessation or withdrawal;
Added:(k) Details of authorisation: procedure type (national (including Member State(s) involved)/ centralised marketing authorisation) and reference;
Added:(l) Member States in which the product is placed on the market.
Added:(2) Details of action (suspension, cessation or withdrawal):
Added:(a) Category of action (suspension, cessation or withdrawal);
Added:(b) Available stock up to start date of action;
Added:(c) Start date of action, per Member State;
Added:(d) Reason for action and information on alternative medicinal product(s), where relevant;
Added:(e) Impacted EU/ EEA countries;
Added:(f) Reference to pending regulatory action, Rapid Alert (quality/ safety) or Quality Defect Report related to the action, if relevant;
Added:(g) Other competent authorities notified;
Added:(h) Any actions completed or planned based on a request of the competent authorities of the Member State concerned.
Added:(3) Contact details
Added:(a) Marketing authorisation holder name and address;
Added:(b) Name and contact details of person notifying.
Added:Part II
Added:Risk assessment of impact of suspension, cessation or withdrawal
Added:For the purpose of the request made by the competent authority concerned in accordance with Article 118(2), the marketing authorisation holder shall notify at least the following information:
Added:(1) Risk assessment of impact of suspension, cessation or withdrawal, including:
Added:(a) Potential alternative medicinal products;
Added:(b) Estimated market share per Member State in previous 12 months;
Added:(c) Quantities delivered per month per Member State in previous 12 months;
Added:(d) Manufacturing capacity globally per manufacturing site;
Added:(e) Forecast of supply per month and per Member State until suspension, cessation or withdrawal occurs;
Added:(f) Forecast of demand per month and per Member State in next 6 months;
Added:(g) Impact on the supply of other medicinal products from the same marketing authorisation holder;
Added:(h) Potential impact on the consumption of or demand for other medicinal products.
Added:(2) Any risk-mitigating measures taken by the marketing authorisation holder to address the shortage.
Added:Part III
Added:Information to be provided in case of a temporary disruption of supply (to monitor potential or actual shortage)
Added:For the purpose of the notification in accordance with Article 116(1), point (d) the marketing authorisation holder shall notify the following information:
Added:(1) Product details
Added:(a) Product name;
Added:(b) Active substance(s) and active substance manufacturer(s);
Added:(c) Finished product manufacturer;
Added:(d) Therapeutic indication(s);
Added:(e) ATC code;
Added:(f) Pharmaceutical form;
Added:(g) Strength(s);
Added:(h) Route(s) of administration;
Added:(i) Affected pack size;
Added:(j) Alternative, pharmaceutical form, strength, route of administration or pack size, not affected by the supply disruption;
Added:(k) Details of authorisation: procedure type (national (including Member State(s) involved)/ centralised marketing authorisation) and reference;
Added:(l) Member States in which the product is placed on the market.
Added:(2) Details of supply disruption
Added:(a) Shortage status (actual, potential);
Added:(b) Available stock per month
Added:(c) Expected start date of shortage by Member State;
Added:(d) Expected end date of shortage by Member State;
Added:(e) Reason for shortage; providing, where applicable, information on:
Added:(i) raw material disruption;
Added:(ii) API disruption;
Added:(iii) excipient disruption;
Added:(iv) production problems;
Added:(v) quality problems;
Added:(vi) production capacity;