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Pharma Horizon Legal Section


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.





16/09/2017 0- Corrigendum to Council Regulation (EU) 2017/1398 of 25 July 2017 amending Regulation (EU) 2017/127 as regards certain fishing opportunities

16/09/2017 – Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use

16/09/2017 – Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections

15/09/2017 – Notification to the Joint Sectoral Committee by the European Union under Article 7 of the Sectoral Annex on Pharmaceutical Good Manufacturing Practices (GMPs) of the Agreement on Mutual Recognition between the European Community and the United States of America

28/08/2017 – Judgment of the Court (Eighth Chamber) of 28 June 2017 — Novartis Europharm Ltd v European Commission, Teva Pharma BV (C-629/15 P), Hospira UK Ltd (C-630/15 P) (Joined Cases C-629/15 P and C-630/15 P) (1) ((Appeal – Medicinal products for human use – Marketing authorisation – Regulation (EEC) No 2309/93 – Centralised procedure at European Union level – Development of a medicinal product that was the subject of a marketing authorisation for other therapeutic indications – Separate marketing authorisation and new trade name – Directive 2001/83/EC – Second subparagraph of Article 6(1) and Article 10(1) – Concept of a ‘global marketing authorisation’ – Regulatory data protection period))

10/08/2017 – Commission Implementing Decision (EU) 2017/1445 of 8 August 2017 on the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry (Vaccinium macrocarpon), is to prevent or treat cystitis

07/07/17 Report on activity of the Expert Group on Safe and Timely Access to Medicine for Patients (STAMP) 2015 – 2016.

30/07/2017 The EC has approved Sandoz’ Rixathon (biosimilar rituximab) for use in Europe  to treat multiple inflammatory diseases.

30/06/2017 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2017 to 31 May 2017

30/06/2017 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2017 to 31 May 2017

14/06: Leading European health start ups join forces to better serve insurers.

12/06: Risk, benefit or cost: What stops patients from receiving a diagnostic test?

08/06: Global study sets new standard to personalise chemotherapy.

07/06: New Chesar version eases generation and updating of chemical safety reports

07/06: Commission Implementing Regulation (EU) 2017/963 of 7 June 2017 concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase produced by Aspergillus aculeatinus (formerly classified as Aspergillus aculeatus) (CBS 589.94), endo-1,4-beta-glucanase produced by Trichoderma reesei (formerly classified as Trichoderma longibrachiatum) (CBS 592.94), alpha-amylase produced by Bacillus amyloliquefaciens (DSM 9553), endo-1,4-beta-xylanase produced by Trichoderma viride (NIBH FERM BP4842) and bacillolysin produced by Bacillus amyloliquefaciens (DSM 9554) as a feed additive for all avian species and weaned piglets and amending Regulations (EC) No 358/2005 and (EU) No 1270/2009 (holder of the authorisation Kemin Europa NV) (Text with EEA relevance. )

24/05: Better, cheaper healthcare with dry blood samples.

24/05: FDA approves first cancer treatment for any solid tumor with a specific biomarker.

24/05: Commission Implementing Regulation (EU) 2017/895 of 24 May 2017 concerning the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening and laying hens (holder of authorisation Fertinagro Nutrientes S.L.).

23/05: Biosimilar medicines: Dramatic increase in patient access across Europe.

16/05: Lesson from Ebola: How to improve disease outbreak management.

17/05: Can crab shells provide a green solution to malaria?

17/05: EC opens formal investigation into Aspen Pharma’s cancer drug price hikes.

16/05: First-in-class innovation a key strategy for harsh pharma market environment.

15/05: Antitrust: Commission opens formal investigation into Aspen Pharma’s pricing practices for cancer medicines.

12/05: Alzheimer’s expert call for changes in FDA drug approval standards.

12/05: Commission Implementing Regulation (EU) 2017/795 of 10 May 2017 approving pyrogenic, synthetic amorphous, nano, surface treated silicon dioxide as an existing active substance for use in biocidal products of product-type 18.

12/05: The continuum of HIV care: What does it mean and how is Europe doing?

10/05: Commission Implementing Regulation (EU) 2017/794 of 10 May 2017 approving silicon dioxide Kieselguhr as an existing active substance for use in biocidal products of product-type 18.

04/05: FDA approves new combination treatment for acute myeloid leukaemia.

04/05: FDA approves Roche’s high-volume immunoassay.

04/05: First ever evidence of treatment-induced reduction in HIV reservoirs.

03/05: Commission Regulation (EU) 2017/771 of 3 May 2017 amending Regulation (EC) No 152/2009 as regards the methods for the determination of the levels of dioxins and polychlorinated biphenyls (Text with EEA relevance. )

02/05: NICE recommends Janssen’s Crohn’s Disease biological therapy.

28/04: First new promising treatment in a decade for primary liver cancer patients.

28/04: Six opinions adopted by the Biocidal Products Committee.

28/04: Chemical products with old labels off the shelves by 1 June 2017.

27/04: All known substances of very high concern being tackled.

27/04: AstraZeneca’s lung cancer drug receives full approval in the EU.

27/04: Protein targeting antibiotics bring new hope against multi-drug resistance.

26/04: FDA takes action against 14 companies for selling illegal cancer treatments.

20/04/17: Targovax initiates clinical immunotherapy trial to treat RAS-mutated cancer.

20/04/17: Novartis expands development programs for NASH with Allergan clinical partnership.

18/04/17: Rigel submits new drug application to FDA for Fostamatinib in Chronic ITP.

18/04/17: Amarantus forms Elto Pharma for CNS Disorders and MANF Therapeutics for Ophthalmology.

13/04/17: Study finds genetic basis for drug response in childhood absence epilepsy.

6/04/17: BTG receives CE mark certification for radiopaque drug-eluting bead.

6/04/17: Proposal for a COUNCIL IMPLEMENTING DECISION on subjecting the new psychoactive substance N-(1-phenethylpiperidin-4-yl)-N-phenylacrylamide (acryloylfentanyl) to control measures.

5/04/17: New report reveals little progress on 2014 WHO psoriasis recommendations.

24/03/17: NICE asks BMS for more data before approving cancer drug.

20/03/17: Re-formulation of microbicidal lubricants will help protect from HIV.

20/03/17: Debiopharm’s triptorelin 6-month formulation receives EU approval.

20/03/17: Fixed dose combination of drugs versus single-drug formulations to treat tuberculosis.

17/03/17: Statement of revenue and expenditure of the European Medicines Agency for the financial year 2017.

15/03/17: Developing nanopreparation properties for use in anticancer medicines.

14/03/17: New economic data finds Novo Nordisk’s insulin degludec most cost effective diabetic treatment.

14/03/17: Sandoz biosimilar adalimumab study shows equivalent efficacy.

13/03/17: Business Planet: Lyon – a stronghold for entrepreneurship in France.

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.

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.

27/02/2017 – Targeted stakeholder consultation on the revised guidelines on excipients in the labelling and package leaflet of medicinal products for human use

27/01/2017 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2016 to 31 December 2016 (*)

27/01/2017 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2016 to 31 December 2016 (*)

24/01/2017 – Conditional marketing authorisations give patients access to important new medicines earlier

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 (*)

23/01/2017 – Commission publishes Q&A on biosimilar medicines for patients

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) (*)

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 (*)

18/11/2016 – Statement of Commissioner Andriukaitis on the occasion of European Antibiotic Awareness Day

18/11/2016 – Commission notice on the application of Articles 3, 5 and 7 of Regulation (EC) No 141/2000 on orphan medicinal products (*)

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  (*)

15/11/2016 – New psychoactive substances in Europe: legislation and prosecution — current challenges and solutions

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)

28/10/2016 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016

28/10/2016 – Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016 (*)

27/10/2016 – Speech by Commissioner Vytenis Andriukaitis at the Lithuanian Conference on Challenges in Addressing the Issue of Antimicrobial Resistance

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

24/10/2016 – Crossing a border for a medical treatment: Commission publishes data from 23 Member States

19/10/2016 – Fixed prices set in Germany for prescription-only medicinal products are contrary to EU law

18/10/2016 – Commission implementing regulation (EU) 2016/1834 of 17 October 2016 amending Regulation (EU) No 37/2010 as regards the substance monepantel

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)