The mutual recognition of inspections of certain veterinary medicines between the European Union and the United States has reached a significant milestone.
The first version of the Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing and the associated templates were finalised in March and April 2023 and are now available on the APIC website.
The European Medicines Agency (EMA) publishes information on human medicinal products at various stages of their life cycle, from the early developmental stages through to EMA’s evaluation of authorisation applications, post-authorisation changes, safety reviews and withdrawals of authorisation.
On 17th of May 2023, EMA published recommendations for industry on the good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.
According to a draft version for the German Cannabis Law (Cannabisgesetz, CannG), cannabis for medical purposes will no longer fall within the scope of the Narcotics Law (Betäubungsmittelgesetz, BtMG).
The European Medicines Agency (EMA) has published a new version of the "3-year work plan for the Quality domain" for the period January 2021 - December 2023.
In order to protect public health, the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (hereinafter: the JAZMP) shall, with regard to medicinal products without marketing authorisations in the Republic of Slovenia in accordance with paragraphs one and two of Article 20 of the Medicinal Products Act (Off. Gazette of the RS, No. 17/14 and No. 66/19, hereinafter: the ZZdr-2), begin implementing the provisions of Article 54 of the ZZdr-2, which transposed Article 126a of Directive 2001/83/EC into Slovenian law.
On 26th of April 2023, the European Commission published proposal for the reform of the EU's pharmaceutical legislation and a proposal for the repeal of Directives 2001/83/EC and 2009/35/EC with Annex.
We are providing our present services to our customers on this foundation. Therefore, we offer you scientific solutions with beneficial impact on your business processes to gain competitive advantages.
Billev Pharma East has been recently awarded the “Excellent SME Slovenia” certificate.
This certificate is issued by The Chamber of Commerce and Industry of Slovenia for SMEs with the intention to certify the trustworthiness of a specific company.
It serves as a reward for business excellence and outstanding business record.
Only the top 0.4% of top ranking SME companies can get it.