See link: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice#ema-inpage-item-10391
This measure was taken to give pharmaceutical companies more time to ensure that the quality and safety of medicines continue to be guaranteed in light of the challenges posed by the pandemic.
June 29, 2023
GMP Compliance Extended Until December 31, 2023
The European Medicines Agency (EMA) has published an update on GMP compliance in light of the COVID-19 pandemic.
This measure was taken to give pharmaceutical companies more time to ensure that the quality and safety of medicines continue to be guaranteed in light of the challenges posed by the pandemic.
Existing GMP compliance certificates are valid through December 31, 2023. This is stated in the publication dated August 11, 2022, under section 2.2 (“The validity of GMP certificates for manufacturing/importing sites of active substances and/or finished products in the EEA should be extended until the end of 2023 without the need for further action from the certificate holder.”).
The publication of these guidelines demonstrates the EMA’s commitment to addressing the challenges arising from the COVID-19 pandemic. The agency is actively working to ensure that the pharmaceutical industry continues to fulfill its responsibility to produce safe, high-quality medicines. By extending GMP compliance, companies have the opportunity to ensure that the supply of essential medicines is maintained.
Your Partner for Quality, Safety, and Compliance
The life sciences sector requires specialized knowledge and reliable support. With our comprehensive expertise, we help companies comply with laws and regulations, ensure quality, and continue to innovate with confidence.
Related Services
Related Articles
18 Jun 2026
19%—a fee you’ll never have to pay again.
Normec Hybeta’s hygiene services are exempt from sales tax under the applicable legal requirements. Not a discount. Not a special offer. But a structural advantage that extends across your entire facility—from operating rooms to water and air hygiene to hospital hygiene.
01 Apr 2026
Cleanrooms at Medical Device Manufacturers
Commissioning • Monitoring • Requalification
10 Mar 2026
Validation of New Reprocessing Devices – Your Operator Obligations Under the MPBetreibV.
New reprocessing devices (RDG, RDG-E, sterilizers) may only be put into routine operation once their processes have been validated in accordance with the law. The MPBetreibV defines clear requirements for this and specifies who is authorized to perform this validation. An independent, accredited testing laboratory lays the foundation for safe and legally compliant operation from the very first use.
10 Mar 2026
"A great way of interacting with each other—the friendliness and willingness to help one another"
Tatiana Pershukova (37) is a team assistant in the Technical Hygiene and Construction department. In this interview, she talks about her work experience at Normec Hybeta.
10 Dec 2025
Your specialist for microbiological and technical hygiene in the healthcare sector
We are pleased to announce that the identification of microorganisms using the MALDI Biotyper® is now also available through us under an accredited framework (D-PL-17310-01-01) in accordance with DIN EN ISO/IEC 17025:2018!
17 Jun 2025
Normec Hybeta announces:
Hygiene Requirements for the Reprocessing of Thermolabile Endoscopes – Flush-Brush-Flush and the “New” Annex 8
14 Mar 2024
February 29, 2024—a day to celebrate volunteerism!
Two weeks ago today was the day—this year, February gave us an extra day. To make good use of the extra time, we at Normec Hybeta decided to join “Social Day 2024.”