27 Di Renzo Regulatory Affairs
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Italian Regulatory 27 Affairs News 12th July, 2021 •Human Medicines •Veterinary Medicines •Homeopathic Products •Medical Devices •Diagnostics •Food Supplements •PMC (Medical Surgical Aids) •Biocides •Plant Protection Products •Cosmetics
Di Renzo® Regulatory Affairs
headquarters:
Via dell’Arco di Travertino 11
00178 - Rome
registered office:
Viale Manzoni 59
00185 - Rome
Tel. +39 06 / 77 20 90 20
Fax. +39 06 / 70 47 40 67
www.direnzo.biz
regolatorio@direnzo.biz
Italian Regulatory Affairs News
N. 27 - 12th July, 2021
WEEKLY MAGAZINE
Editor in Chief:
Sante Di Renzo
Subeditor:
Maria Pia Felici
Layout:
Maurizio Isopo
Italian Regulatory Affairs News 3
Italian Regulatory Updates
Annual fees 2021
The Italian Medicine Agency made available the indications for the payment of
the annual fees 2021 for MAs valid at 31 December 2020 on their portal.
The Agency also published the list of MAs resulting as valid on a company
basis based on the SIS code and the form to self-certify valid MAs in case of no
correspondence with the information available to the Agency.
Microenterprises, small- and medium-sized enterprise and public companies
are entitled to a 25% reduced payment to be demonstrated by appropriate
documentation or self-certification.
The annual fees are to be paid no later than 31 July.
Di Renzo Regulatory Affairs - headquarters: Via dell’Arco di Travertino 11 - 00178 - Roma - registered office: Viale Manzoni 59 - 00185 Roma
Tel. + 39 06 / 77 20 90 20 - Fax. 06 / 70 47 40 67 - www.direnzo.biz - regolatorio@direnzo.biz
Italian Regulatory Affairs News 4 New list for GMP remote notifications The Italian Medicines Agency has published a new list (05-07-2021) of documents released by the Medicine GMP Inspections and Authorisation Unit that can be received via registered letter. The notification of these documents was suspended due to the pandemic. In order to receive the documents a request shall be submitted to the unit, printed on unstamped paper, and signed by the legal representative, accompanied by the ID of the applicant and including the address for the shipment. After the company’s business name or the name of the QP, the number of revenue stamps of 16€ required for the notification is also indicated (one very 4 pages of the document). The documents concerned by this notification via registered letter include deed of appointment, resignation and replacement of a QP of a pharmaceutical manufacturing site and deed of suitability to act as QP at pharmaceutical manufacturing sites (for which 1 revenue stamp will be sufficient); GMP, CPP and CPO certificates (1 or 2 stamps); decrees of manufacturing authorisations (MIAs), including change of the trade name, ownership, legal office or address (2 or 3 stamps). With the relevant document, companies will also receive a note to be sent back signed, as notification receipt. Authorising letters for changes to the authorisation not requiring the release of a new MIA are already advanced via e-mail. Di Renzo Regulatory Affairs - headquarters: Via dell’Arco di Travertino 11 - 00178 - Roma - registered office: Viale Manzoni 59 - 00185 Roma Tel. + 39 06 / 77 20 90 20 - Fax. 06 / 70 47 40 67 - www.direnzo.biz - regolatorio@direnzo.biz
Italian Regulatory Affairs News 5 Active substances, medicines and medical gases: manufacturers’ lists updated The Italian Medicine Agency has published the list of manufacturing sites authorised and/or registered for the manufacturing of active substances (including medical gases) updated up to 30 June 20201. All concerned companies can report any inconsistency via e-mail, to the dedicated certified e-mail address, enclosing the required supporting documentation. The list of manufacturing sites authorised for the manufacturing of medical gases (excluding gases registered as raw materials, that are included in the list of active substances), also updated up to 30 June 2021, has also been published. The lists are available in the Agency website. Unlimited MAs for veterinary drugs The Italian Ministry of Health has reminded that, according to Regulation (EU) 2019/6, the submission of renewal applications for veterinary medicinal products authorised by national, mutual recognition or decentralised procedures will not be required anymore. As such application is to be submitted 6 months before the expiry of the validity (5 years), considering that the Regulation becomes applicable on 28 January 2022, the obligation to submit the renewal application for veterinary products applies as early as of 28 July. Di Renzo Regulatory Affairs - headquarters: Via dell’Arco di Travertino 11 - 00178 - Roma - registered office: Viale Manzoni 59 - 00185 Roma Tel. + 39 06 / 77 20 90 20 - Fax. 06 / 70 47 40 67 - www.direnzo.biz - regolatorio@direnzo.biz
Italian Regulatory Affairs News 6 CPP forms updated As of 1st July, the form to be filled in by the applicants of the certificate of pharmaceutical product (CPP) for medicinal products authorised by national, mutual recognition or decentralised procedure has changed. No CE mark for air purifiers and sanitisers The Italian Ministry of Health has published some clarifications regarding the CE marking of air purifiers and sanitisers. In particular, in the memorandum letter dated 11 June 2021, the Ministry has specified that, based on their intended use and mode of action, these products do not fall into the definition of medical device. Therefore, manufacturers who applied the CE mark on their products have been invited to delete them from the medical device database and to market these products based on the general provisions on the safety of marketed products according to the Consumers’ Code (Leg.Dec. 206/2005), submitting the CE marking in accordance with other regulations regarding other aspects, such as electric safety. Di Renzo Regulatory Affairs - headquarters: Via dell’Arco di Travertino 11 - 00178 - Roma - registered office: Viale Manzoni 59 - 00185 Roma Tel. + 39 06 / 77 20 90 20 - Fax. 06 / 70 47 40 67 - www.direnzo.biz - regolatorio@direnzo.biz
Italian Regulatory Affairs News 7
European Journals
OJ no. L238 of 6 July 2021 Regulation (EC) No 1223/2009 of the Euro-
Commission Regulation (EU) 2021/1098 of pean Parliament and of the Council on cosme-
2 July 2021 amending Annexes II, III and IV tic products.
to Regulation (EC) No 396/2005 of the Euro-
pean Parliament and of the Council as regards
OJ no. L239 of 7 July 2021
maximum residue levels for 24-epibrassinoli-
Commission Regulation (EU) 2021/1110 of
de, Allium cepa L. bulb extract, cyflumetofen,
6 July 2021 amending Annexes II and III to
fludioxonil, fluroxypyr, sodium 5-nitroguaia-
Regulation (EC) No 396/2005 of the Europe-
colate, sodium o-nitrophenolate and sodium an Parliament and of the Council as regards
p-nitrophenolate in or on certain products.maximum residue levels for ametoctradin,
bixafen, fenazaquin, spinetoram, tefluthrin
Commission Regulation (EU) 2021/1099 of and thiencarbazone-methyl in or on certain
5 July 2021 amending Annexes II and III to products.
Di Renzo Regulatory Affairs - headquarters: Via dell’Arco di Travertino 11 - 00178 - Roma - registered office: Viale Manzoni 59 - 00185 Roma
Tel. + 39 06 / 77 20 90 20 - Fax. 06 / 70 47 40 67 - www.direnzo.biz - regolatorio@direnzo.biz
Italian Regulatory Affairs News 8
The European Committees
Committee for Medicinal Products for Pharmacovigilance Risk Assessment
Human Use (CHMP) Committee (PRAC)
Last meeting: 21-24 June 2021 Last meeting: 5-8 July 2021
Next meeting: 19-22 July 2021 Next meeting: 2-5 August 2021
Committee for Advanced Therapies (CAT) Committee for herbal Medicines
Last meeting: 16-18 June 2021 (HMPC)
Next meeting: 14-16 July 2021 Last meeting: 5-7 July 2021
Next meeting: 20-22 September 2021
Paediatric Committee (PDCO)
Last meeting: 22-25 June 2021 Committee for Medicinal Products for
Next meeting: 20-23 July 2021 Veterinary Use (CVMP)
Last meeting: 15-17 June 2021
Committee for Orphan Medicinal Next meeting: 13-15 July 2021
Products (COMP)
Last meeting: 15-17 June 2021 Committee on Biocides (BPC)
Next meeting: 13-15 July 2021 Last meeting: 14-18 June 2021
Next meeting: 4-15 October 2021
Di Renzo Regulatory Affairs - headquarters: Via dell’Arco di Travertino 11 - 00178 - Roma - registered office: Viale Manzoni 59 - 00185 Roma
Tel. + 39 06 / 77 20 90 20 - Fax. 06 / 70 47 40 67 - www.direnzo.biz - regolatorio@direnzo.biz
Italian Regulatory Affairs News 9
The Italian Commissions
Open-AIFA: NA Technical Scientific Advisory
Commission/ Committee for prices and
AIFA Board of Directors reimbursement joint meeting:
Last meeting: 17 June 2021 Last meeting: 18 June 2021
Next meeting: 15 July 2021 Next meeting: 16 July 2021
Technical Scientific Advisory The Technical Health Committee
Commission Advertisement
Last meeting: 7 July 2021 Last meeting: 6 July 2021
Next meeting: 8 September 2021 Next meeting: 26 July 2021
The Committee for prices and Veterinary Commission
reimbursement Last meeting: 8 July 2021
Last meeting: 23 June 2021 Next meeting: 5 October 2021
Next meeting: 20 July 2021
Di Renzo Regulatory Affairs - headquarters: Via dell’Arco di Travertino 11 - 00178 - Roma - registered office: Viale Manzoni 59 - 00185 Roma
Tel. + 39 06 / 77 20 90 20 - Fax. 06 / 70 47 40 67 - www.direnzo.biz - regolatorio@direnzo.biz
Italian Regulatory Affairs News 10
Update on the measures adopted by Di
Renzo Regulatory Affairs in compliance
with the provisions to contrast the sprea-
ding of the COVID-19 epidemic
Di Renzo Regulatory Affairs has resumed its business
operations at its headquarters, continuing to apply all
measures and actions requested by the provisions of
the President of the Ministry Council in order to con-
tain the spreading of the concerned virus.
Risk minimisation and staff protection will always be
ensured, together with the full continuity of all opera-
tions and services.
Di Renzo Regulatory Affairs will answer calls and
e-mails during the ordinary working hours from the
usual telephone numbers and e-mail addresses, ensu-
ring contacts between the clients and their dedicated
people as well as assistance to all companies that will
require it.
The adopted measures, together with a common sen-
se of responsibility, optimism and confidence, are the
contribution of Di Renzo Regulatory Affairs to over-
come this delicate moment.
Di Renzo Regulatory Affairs - headquarters: Via dell’Arco di Travertino 11 - 00178 - Roma - registered office: Viale Manzoni 59 - 00185 Roma
Tel. + 39 06 / 77 20 90 20 - +39 06 / 89 68 35 18 - Fax. 06 / 70 45 00 99 - www.direnzo.biz - regolatorio@direnzo.bizDi Renzo Regulatory Affairs
Di Renzo® Regulatory Affairs
headquarters: Via dell’Arco di Travertino 11 - 00178 Rome
registered office: Viale Manzoni 59 - 00185 Rome
Tel. +39 06 / 77 20 90 20 - Fax. +39 06 / 70 47 40 67
www.direnzo.biz
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