The new law implementing the EU rules on falsified medicines which has been applicable since February 2019 (Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human
The President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued two more Brexit related communiques. The first Brexit related communique concerned changes to: data which was included within marketing permissions, data being made available on the market, and data concerning the use of biocidal products. The second
On Monday, March 4, the President signed a bill on the establishment of a new institution, the Medical Research Agency (ABM). The new Agency will be a specialized body of experts who will work on innovation in Polish medicine, focusing on areas related to oncology, haematology and rare diseases. The activities of the Agency will
On 25 February 2019, the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event of a “no-deal” Brexit. In the event of a “no-deal” Brexit, the President of the Office has recommended that companies immediately introduce post-registration
The President of the Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products (URPL) estimates that approximately 20% of all the 10,000 medicinal products registered in Poland will be affected by the effects of Brexit. Out of this number, according to media reports, new reimbursement decisions will need to be issued for
The concept paper The EMA has published a “Concept paper on preparation of a revised guideline on the evaluation of medicinal products indicated for treatment of bacterial infections.” In the Concept Paper, the EMA proposes to merge the “Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev 2)” with
The UK House of Commons Health and Social Care Committee has published the findings of its six-month long investigation into the impact of Brexit on medicines, medical devices and substances of human origin. The Committee’s report sets out recommendations for the UK Government in its negotiations with the EU on the terms of the UK’s
Fast track for orphan diseases and rare forms of cancers By Ministerial Decree of 7 September 2017 (DM 7 September 2017), published in the Italian Official Journal on 2nd November2017, the Ministry of Health enacted new rules on expanded access to medicinal products, for which the authorisation procedure is still on-going, replacing the former Ministerial
The European Commission updated Good Manufacturing Practice requirements for medicinal products.
The European Commission has published a guidance concerning “Safety Features for medicinal products for human use” (Guidance). The Guidance is in the form of a “Questions and Answers” document. It is intended to facilitate the implementation of the EU Falsified Medicines legislation.
The European Medicines Agency (EMA) has released a concept paper concerning a proposed revision of the current guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells. The proposed revision will update the previous Guideline of 2012. EMA’s concept paper is intended to address the issue that the current guideline does
By Ministerial Circular of 23 March 2017, the Ministry of Health clarified the conditions under which unauthorised medicinal products may be purchased abroad within the procedure laid down by the Ministerial Decree of 11 February 1997.
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on common mistakes made by applicants, to help reduce delays in processing applications. The MHRA is required to grant or refuse applications for manufacturing authorisations within 90 days of receiving a completed application. The
On 12 August 2015, the European Commission notified the World Trade Organisation (“WTO”) of its draft Delegated Regulation supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the outer packaging of medicinal products for human use (hereafter “draft Commission Delegated Regulation”).
On 1 July 2015, the new common logo for online pharmacies and retailers offering medicinal products for human use in the European Union (“EU”) will come into effect. The purpose of the logo is to contribute to reduction in the threat of the circulation of falsified medicinal products. It is anticipated that the logo will enable customers to identify persons who are authorised or entitled to sell medicinal products at a distance to the public through a website.
From 1 July 2015, any UK-based online retailer that sells medicines to consumers in the UK or any EU or European Economic Area (EEA) country must be registered with the UK competent authority, the Medicines and Healthcare Products Regulatory Agency (MHRA). They must also display the EU common logo for online retailers and pharmacies, together
The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has published new guidance on data integrity in the context of good manufacturing practices (GMP).
On 25 September 2014 the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) announced new simplified guidance for healthcare professionals reporting suspected adverse drug reactions (“ADR”) in children in the UK.
The European Medicines Agency has launched a pilot project to consult with patients during the assessment of the benefit/risk profile of medicinal products by the Agency’s Committee for Medicinal Products for Human Use and Pharmacovigilance Risk Assessment Committee.
On 3 October 2013, the Court of Justice of the European Union issued a judgment in Case C-109/12, which concerned the implications of classification of a product as both a medical device and as a medicinal product within the same EU Member State and within the European Union (hereinafter “EU”) Internal Market. The case responds
On 7 March 2013, the European Commission adopted a black triangle as the symbol to be placed on the patient information leaflets and the Summary of Product Characteristics (“SmPC”) of medicinal products “subject to additional monitoring” in the European Union (“EU”). The history of the black triangle The requirement to include a black symbol in