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 41 of 42: Paragraphs 2392–2451
Added:(vii) logistics problems;
Added:(viii) distribution problems;
Added:(ix) inventory and storage practices;
Added:(x) increase in demand;
Added:(xi) commercial reasons; and
Added:(xii) any other reasons; [Am. 365]
Added:(f) Impacted EU/ EEA countries and where available other impacted countries;
Added:(g) Reference to pending regulatory action, Rapid Alert (quality/ safety) or Quality Defect Report related to the action, if relevant;
Added:(h) Other competent authorities notified;
Added:(i) Any actions completed or planned based on a request of competent authorities of 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 IV
Added:The Shortage Mitigation Plan
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. Shortage mitigation plan, detailing the risk assessment of impact of shortage, including, where available:
Added:(a) Potential alternative medicinal products;
Added:(b) Estimated market share by 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 for the duration of the shortage,
Added:(f) Forecast of demand per month and per Member State for the duration of the shortage;
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:(i) Any risk-mitigating measures taken or planned by the marketing authorisation holder to address the shortage.
Added:Part V
Added:The shortage prevention plan
Added:The Shortage Prevention Plan referred to in Article 117 shall contain the following minimum set of 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) ATC code;
Added:(e) Therapeutic indication(s);
Added:(f) Pharmaceutical form;
Added:(g) Strength(s);
Added:(h) Route(s) of administration;
Added:(i) Pack size(s);
Added:(j) Details of authorisation: procedure type (national (including Member State(s) involved)/ centralised marketing authorisation) and reference;
Added:(k) Member States in which the product is placed on the market.
Added:(2) Shortage prevention measures and supply chain risk assessment:
Added:(a) Alternative marketed medicinal products;
Added:(b) Supply chain map, with risk identification and analysis with particular attention to supply chain vulnerabilities;
Added:(c) Shortage management measures, to include:
Added:(i) a risk control strategy in place, to include information on strategies to minimise risks of shortages and how these are implemented;
Added:(ii) a process for the detection and notification of supply disruptions and
Added:(iii) a record of root causes of resolved shortages and mitigation measures taken for those shortages.
Added:(d) Process for check of effectiveness, review and update of the shortage prevention plan.
Added:(da) methodology for establishing the demand forecast. [Am. 366]
Added:(3) Contact details
Added:(a) Marketing authorisation holder name and address;
Added:(b) Name and details of contact person.
Added:Part Va
Added:For the purposes of reporting in accordance with Article 118(1) and for the early detection of supply shortages, wholesalers shall provide the following information in a timely manner:
Added:1. Product availability information:
Added:Product availabilities shall be reported per warehouse and shall be indexed as yes/no.
Added:2. Service level information:
Added:Service level information which captures the level of fulfilment of wholesale orders by marketing authorisation holders and suppliers shall be reported. Such information involves comparing the quantity ordered with the quantity actually received at the product level. The resulting difference describes the service level. [Am. 367]
Added:Annex V