Swissmedic Vigilance News
Edition 31 – November 2023
Edition 31 – November 2023
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22.09.2023<br />
<strong>Swissmedic</strong> approves Pfizer coronavirus vaccine Comirnaty<br />
XBB.1.5<br />
Comirnaty XBB.1.5 approved for persons aged 12 and<br />
over<br />
15.09.2023<br />
Changes to the guidance document Temporary authorisation<br />
of human medicinal products<br />
Clarification regarding authorised medicinal products,<br />
harmonised deadlines for applications before expiry of<br />
temporary authorisation and changes to terminology<br />
10.09.2023<br />
SwissGMDP database<br />
<strong>Swissmedic</strong> is bringing a SwissGMDP database into operation,<br />
similar to the European Medicine Agency's (EMA)<br />
EudraGMDP database<br />
06.09.2023<br />
Complementary and herbal medicines containing ethanol<br />
in paediatric populations<br />
The benefits of the use of the medicinal product containing<br />
ethanol must outweigh the potential risks<br />
01.09.2023<br />
Allocation of medicinal product groups for CHM<br />
has been updated<br />
24.08.2023<br />
Potential risk to children whose fathers have taken the<br />
active substance valproaten<br />
Precautionary change to the medicinal product information<br />
for valproate products<br />
17.08.2023<br />
Benchmarking study 2022<br />
International comparison of Swiss authorisation times<br />
02.08.2023<br />
<strong>Swissmedic</strong> participation in the European Medicines<br />
Agency (EMA) OPEN initiative<br />
Opening procedures at EMA to non-EU authorities (OPEN)<br />
initiative<br />
27.07.2023<br />
MRA between Switzerland and the USA on the manufacturing<br />
practice for medicinal products takes effect<br />
Mutual recognition in principle of inspections by <strong>Swissmedic</strong><br />
and the FDA<br />
26.07.2023<br />
Establishment licence for Dr. Heinz Welti AG: Suspension<br />
of establishment licence at Bubendorf site lifted<br />
Suspension for Dr. Heinz Welti AG fully lifted<br />
26.07.2023<br />
Switzerland becomes Official Observer in the International<br />
Cooperation on Harmonisation of Technical Requirements<br />
for Registration of Veterinary Medicinal Products<br />
(VICH)<br />
<strong>Swissmedic</strong> amends donation criteria at request of Swiss<br />
Transfusion SRC<br />
25.07.2023<br />
New blood donation criteria for men who have sex with<br />
men<br />
<strong>Swissmedic</strong> amends donation criteria at request of Swiss<br />
Transfusion SRC<br />
14.07.2023<br />
Trips abroad with medications – what you need to know<br />
Anyone who relies on medication should find out about<br />
the regulations in their destination country and any<br />
countries they travel through before taking a trip abroad<br />
07.07.2023<br />
Public Consultation on ICH Reflection Paper launched in<br />
Switzerland<br />
International Harmonisation of Real-World Evidence Terminology<br />
and Convergence of General Principles Regarding<br />
Planning and Reporting of Studies Using Real-World<br />
Data, with a Focus on Effectiveness of Medicines<br />
05.07.2023<br />
Nitrosamine impurities in medicinal products: <strong>Swissmedic</strong><br />
sets up specialist group<br />
“Nitrosamine Specialist Group”: centre of expertise and<br />
coordination office for nitrosamine issues<br />
23.06.2023<br />
Meeting of the International Council for Harmonisation<br />
of Technical Requirements for Pharmaceuticals for Human<br />
Use (ICH)<br />
New Areas of Harmonisation adopted alongside Significant<br />
Advancement of Ongoing Activities in Vancouver,<br />
Canada<br />
22.06.2023<br />
Changes to the guidance document on biosimilars<br />
Update of section 5.10 on interchangeability<br />
<strong>Swissmedic</strong> <strong>Vigilance</strong> <strong>News</strong> | Edition 31 – November 2023<br />
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