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Pharma Horizon Legal Section


michela-velardo

Michela Velardo who previously worked at FieldFisher law firm and the Legal Service of the European Commission, has extensive expertise in European and national litigation. At this time, she has pleaded 140 cases in various fields of European Law. Michela regularly assists chemicals manufacturers (in relation to REACH, biocides and pesticides) and food companies, also on regulatory matters. Furthermore, she deals with case law of European Civil Service Law, European Social Law and International Employment Law. Michela, who works fluently in English, French and Italian, frequently speaks in conferences and writes articles for international law journals and magazines.

Email: michela.velardo@scea.eu

 

LATEST UPDATES

 

24/03/17: NICE asks BMS for more data before approving cancer drug.
https://www.europeanpharmaceuticalreview.com/49906/news/industry-news/nice-hodgkin-lymphoma/

20/03/17: Re-formulation of microbicidal lubricants will help protect from HIV.
https://www.europeanpharmaceuticalreview.com/49668/news/industry-news/re-formulation-microbicidal-lubricants/

20/03/17: Debiopharm’s triptorelin 6-month formulation receives EU approval.
https://www.europeanpharmaceuticalreview.com/49655/news/industry-news/debiopharms-month-formulation/

20/03/17: Fixed dose combination of drugs versus single-drug formulations to treat tuberculosis.
https://www.europeanpharmaceuticalreview.com/49714/news/industry-news/formulations-treat-tuberculosis/

17/03/17: Statement of revenue and expenditure of the European Medicines Agency for the financial year 2017.
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ%3AJOC_2017_084_R_0007

15/03/17: Developing nanopreparation properties for use in anticancer medicines.
https://www.europeanpharmaceuticalreview.com/49470/news/industry-news/developing-nanopreparation/

14/03/17: New economic data finds Novo Nordisk’s insulin degludec most cost effective diabetic treatment.
https://www.europeanpharmaceuticalreview.com/49386/news/industry-news/new-economic-data-diabetes/

14/03/17: Sandoz biosimilar adalimumab study shows equivalent efficacy.
https://www.europeanpharmaceuticalreview.com/49380/news/industry-news/sandoz-biosimilar-adalimumab-study-shows-equivalent-efficacy/

13/03/17: Business Planet: Lyon – a stronghold for entrepreneurship in France.
http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=9098&lang=en

13/03/17: Commission Implementing Regulation (EU) 2017/439 of 13 March 2017 concerning the authorisation of L-lysine sulphate produced by Escherichia coli as a feed additive for all animal species.
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0439&from=EN

13/03/17: Commission Implementing Regulation (EU) 2017/438 of 13 March 2017 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance abamectin.
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0438&from=EN

27/02/2017 – Targeted stakeholder consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use
http://ec.europa.eu/health/human-use/legal-framework/developments/2017_pc_guidelines_excipient_en

27/01/2017 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2016 to 31 December 2016
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52017XC0127(03)&from=EN (*)

27/01/2017 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2016 to 31 December 2016
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52017XC0127(02)&from=EN (*)

24/01/2017 – Conditional marketing authorisations give patients access to important new medicines earlier
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/01/news_detail_002680.jsp&mid=WC0b01ac058004d5c1

24/01/2017 – Commission Regulation (EU) 2017/110 of 23 January 2017 amending Annexes IV and X to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0110&from=EN (*)

23/01/2017 – Commission publishes Q&A on biosimilar medicines for patients
http://ec.europa.eu/growth/tools-databases/newsroom/cf/itemdetail.cfm?item_id=9066&lang=en

19/01/2017- Judgment of the Court of 1 February 2016 in Case E-20/15 EFTA Surveillance Authority v Iceland (Failure by an EEA/EFTA State to fulfil its obligations — Failure to implement — Directive 2013/10/EU amending Directive 75/324/EEC on aerosol dispensers)
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:E2015J0020&from=EN (*)

06/01/2017 – Commission Implementing Decision (EU) 2017/9 of 4 January 2017

authorising certain laboratories in Morocco and Taiwan to carry out serological tests to monitor the effectiveness of rabies vaccines in dogs, cats and ferrets
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017D0009&from=EN (*)

18/11/2016 – Statement of Commissioner Andriukaitis on the occasion of European Antibiotic Awareness Day
http://europa.eu/rapid/press-release_IP-16-3805_en.htm

18/11/2016 – Commission notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC1118(01)&from=EN (*)

17/11/2016 – CORRIGENDA Corrigendum to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014R0536R(04)&from=EN  (*)

15/11/2016 – New psychoactive substances in Europe: legislation and prosecution — current challenges and solutions
http://www.emcdda.europa.eu/publications/joint/eurojust/nps-legislation-and-prosecution

15/11/2016- List of stakeholders interested in participating in ad-hoc meetings with representative members of the Competent Authorities on Substances of Human Origin Expert Group (November 2016)
http://ec.europa.eu/health/blood_tissues_organs/docs/2016_call_ls_en.pdf

28/10/2016 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC1028(05)&from=EN

28/10/2016 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52016XC1028(04)&from=EN (*)

27/10/2016 – Speech by Commissioner Vytenis Andriukaitis at the Lithuanian Conference on Challenges in Addressing the Issue of Antimicrobial Resistance
http://europa.eu/rapid/press-release_SPEECH-16-3556_en.htm

25/10/2016 – Commission Regulation (EU) 2016/1872 of 6 October 2016 establishing for 2016 the ‘Prodcom list’ of industrial products provided for by Council Regulation (EEC) No 3924/91
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R1872&from=EN

24/10/2016 – Crossing a border for a medical treatment: Commission publishes data from 23 Member States
http://ec.europa.eu/health/cross_border_care/docs/2015_msdata_en.pdf

19/10/2016 – Fixed prices set in Germany for prescription-only medicinal products are contrary to EU law
http://curia.europa.eu/jcms/upload/docs/application/pdf/2016-10/cp160113en.pdf

18/10/2016 – Commission implementing regulation (EU) 2016/1834 of 17 October 2016 amending Regulation (EU) No 37/2010 as regards the substance monepantel
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R1834&from=EN

13/10/2016 – Summary of the 2015 annual reporting of serious adverse events and reactions (sare) for blood and blood components (data collected from 01/01/2014 to 31/12/2014)
http://ec.europa.eu/health/blood_tissues_organs/docs/2015_sare_blood_summary_en.pdf