Council

• 9 Human Medicines Division Procedural advice on paediatric applications Guidance for applicants 1 1 To be consulted together with the IRIS guide for applicants.
• Placing paediatric medicines on the market ......................................................... 15 Procedural advice on paediatric applications EMA/672643/2017 Rev.
• Regulation (EC) No 1901/2006 (the 'Paediatric Regulation') lays down obligations, rewards and incentives for the development and placing on the market of medicines for use in children.
• Where results of paediatric studies are submitted, applicants should include in the clinical overview a rationale supporting the proposed changes to the Product Information.
• Further information can be found in the Procedural Advice document on ?applications for PIPs, Waivers and Modifications.
• However, the following types of application are exempted from the application of the above requirements: Procedural advice on paediatric applications EMA/672643/2017 Rev.
• Objectives The Paediatric Regulation came into force in the European Union (EU) on 26 January 2007.
• Its main impact was the establishment of the Paediatric Committee (PDCO), which is responsible for coordinating the Agency's work on medicines for children.
• For pre-submission interactions: Send a question to the European Medicines Agency Procedural advice on paediatric applications EMA/672643/2017 Rev.
• for modification of a paediatric investigation plan) it is suggested to record all successive name changes in the document.? Invented name: The trade name of a medicine.
• In general paediatric investigation plans should be submitted early during product development, in time for studies to be conducted in the paediatric population, where appropriate, before marketing authorisation applications are submitted.
• It is often referred to as full waiver as it is related the age range covering all paediatric subsets.
• During the second PDCO discussion, either a request for modification (RfM) or PDCO opinion is adopted: Procedural advice on paediatric applications EMA/672643/2017 Rev.
• Opinion According to Article 25(1) of the Paediatric Regulation (Regulation (EC) No 1901/2006), within ten days of its receipt, the Agency shall transmit the opinion of the Paediatric Committee to the applicant.
• The following documents should be uploaded into ?Documents from applicant? in addition to the IRIS application for the related initial PIP: ? Detailed grounds for re-examination in a Word document Procedural advice on paediatric applications EMA/672643/2017 Rev.
• EMA decision According to Article 25(5) of the Paediatric Regulation (Regulation (EC) No 1901/2006), the Agency issues its decision within 10 days of the Paediatric Committee's definitive opinion.
• The following documents should be uploaded into ?Documents from applicant? in addition to the IRIS application for Discontinuation of paediatric development: Procedural advice on paediatric applications EMA/672643/2017 Rev.
• See also: Deadlines for placing paediatric medicines on the market Procedural advice on paediatric applications EMA/672643/2017 Rev.

• The European Parliament (EP) elections being held this week will likely alter the political orientation of the European Union’s main legislative and budgetary authority, the only directly elected EU body.
• Parties that are skeptical about European integration, along with populist right-wing politicians, are expected to gain ground, while centre-left and Green parties are poised to lose votes and seats.
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  Read more:
  Germany lowers voting age to 16 for the European elections – but is it playing into the far right's hands?

Turnout challenges

• In 2019, overall turnout for the EP elections was under 51 per cent, still an improvement on the turnout of only around 43 per cent in both the 2014 and 2009 elections.
• The elections are taking place in different countries on different dates, from June 6 to June 9.
• Belgian and French police recently searched EP offices on suspicion that MEPs were approached and offered money to promote Russian propaganda.

What does the European Parliament do?

• The EP is often considered weaker than the European Council, which represents the member states, or the European Commission, which forms the EU’s executive branch together with the Council.
• Canada’s formal relationship is the oldest the EU has with any industrialized country, dating back to 1959 when the EU was known as the European Economic Community.
• Canada and the EU have signed a Strategic Partnership Agreement that includes regular summits between Canada’s prime minister and the presidents of the European Council and European Commission.

How the elections could impact Canada

• The complainant requested information about the reduction in disabled parking bays in a particular location.
• Blaenau Gwent County Borough Council (the Council) provided some information and stated other information was not held.
• The Commissioner’s decision is that, on the balance of probabilities the Council does not hold any additional information falling within the scope of the request.
• The Commissioner does not require any steps to be taken.

• The complainant requested from Monmouthshire County Council (the Council) information relating to Old Monmouth Road.
• The Council refused the request and cited regulation 12(4)(b) (manifestly unreasonable) of the EIR.
• The Commissioner’s decision is that the Council was entitled to rely on regulation 12(4)(b) of the EIR to refuse to comply with the request, and the public interest lies in maintaining the exception.
• The Commissioner does not require the Council to take any further steps as a result of this decision.