Notification Detail

Article 5 and 6 of the draft Order on various measures relating to the fight against the spread of the COVID-19 virus

Notification Number: 2020/128/F (France)
Date received: 14/03/2020
End of Standstill: 23/03/2020
Invocation of the Emergency Procedure: Yes

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Message 002

Communication from the Commission - TRIS/(2020) 00921
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2020/0128/F

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 202000921.EN)

1. Structured Information Line
MSG 002 IND 2020 0128 F EN 14-03-2020 F NOTIF

2. Member State

3. Department Responsible
Direction générale des entreprises – SQUALPI – Bât. Sieyès -Teledoc 151 – 61, Bd Vincent Auriol - 75703 PARIS Cedex 13
tél : 01 44 97 24 55

3. Originating Department
Direction des affaires juridiques du ministère des solidarités et de la santé
14, avenue Duquesne 75007 PARIS
Secrétariat : 01 40 56 65 57/56 95

4. Notification Number
2020/0128/F - S00S

5. Title
Article 5 and 6 of the draft Order on various measures relating to the fight against the spread of the COVID-19 virus

6. Products Concerned
Measures concerning pharmacies open to the public: dispensing of medicines beyond the period of validity of the prescription in the event of chronic illness and delivery of boxes of protection masks to private health professionals

7. Notification Under Another Act

8. Main Content
This draft provides firstly that, in the context of chronic treatment and on an exceptional basis, when the period of validity of a renewable prescription has expired and in order to avoid any interruption of treatment that would be detrimental to the health of the patient, pharmacies open to the public can dispense, in the context of the initially planned dosage, a number of boxes per medicinal product prescribed to guarantee the continuation of treatment until 31 May 2020. Secondly, it provides that boxes of protection masks from the national stock can be distributed free of charge by the pharmacies open to the public mentioned in Article L5125-8 of the French Public Health Code to the following health professionals, according to the priorities defined at national level to confront the health crisis and the stocks available: general practitioners and specialised doctors; dental surgeons; nurses; physiotherapists; midwives; pharmacists.

9. Brief Statement of Grounds
The World Health Organization (WHO) declared that the emergence of a novel coronavirus (COVID-19) constitutes a public health emergency of international concern on 30 January 2020.
The dispensing of medicines to the chronically ill by pharmacies open to the public beyond the period of validity as well as the organisation by these same pharmacies to provide access to protection masks for health professionals constitute measures that respond to the national epidemiological situation.
These measures are necessary, proportionate and adapted to the public health objective being pursued.

10. Reference Documents - Basic Texts
Reference(s) to basic text(s): – Articles L3131-1 and L5125-8 of the French Public Health Code
- Article L161-33 of the French Social Security Code

11. Invocation of the Emergency Procedure

12. Grounds for the Emergency
Emergency measures adapted to protect the population against the serious health threat posed by the novel SARS CoV-2 coronavirus.

13. Confidentiality

14. Fiscal measures

15. Impact assessment

16. TBT and SPS aspects
TBT aspect

No - the draft is neither a technical regulation nor a conformity assessment procedure.

SPS aspect

No - the draft is neither a sanitary nor phytosanitary measure.

European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043

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