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The PBL manufacturing facility at Porton im体育, Wiltshire, UK is licensed by the MHRA under the Human Medicines Regulations 2012 (as amended) (SI 2012/1916) Manufacturer’s Licence No. MIA 44403.
In December 2019, following our most recent inspection (October 2019), the MHRA confirmed that the operations are in general compliance with the principles and guidelines of good manufacturing practice as laid down in Commission Directive 2003/94/EC.
Patient safety is our highest priority. The pharmacovigilance department serves patients by monitoring the safety of PBL’s products through the science of Pharmacovigilance. Pharmacovigilance is a comprehensive set of activities focused on the detection, assessment, understanding and prevention of adverse effects or other product-related problems.
The pharmacovigilance team takes a comprehensive and rigorous approach to pharmacovigilance activities. We are dedicated to establishing, maintaining, and communicating quality safety information throughout the life-cycle of PBL’s products. This information helps us better understand, assess, and communicate the safety profile of our products and allows us to deliver safer products to patients.
PBL collects and analyses safety data throughout a product’s life cycle. Product safety is rigorously evaluated during the development process through clinical trials. Not all adverse events associated with the use of a medicinal product are observed in clinical trials. It is therefore important for us to continue to collect adverse events associated with the use of our products even when the product has been approved for use on the market. Once the product receives marketing approval from health authorities, safety data collection continues through multiple channels: additional clinical studies, reports by patients and health care professionals, registries, scientific literature, and external database reviews.
Individual adverse event reports are continuously added to our safety database, and they help contribute to the overall understanding of the safety profile of our products.
To report an adverse event to Porton Biopharma Limited please e-mail drugsafety@portonbiopharma.com
High quality up-to-date information about medicines is essential to optimise their safe and effective use when treating patients The medical information team provides balanced information on clinical aspects of PBL’s products to healthcare professionals (e.g. physicians, pharmacists, nurses) and to patients, in response to a request for information. The team provide consistent and controlled response to these enquiries based upon published literature, confidential company data and experience.
To contact medical information at Porton Biopharma Limited please e-mail medinfo@portonbiopharma.com
Registered in England and Wales, company number im体育. Registered office at Manor Farm Road, Porton im体育, Salisbury, Wiltshire im体育 0JG. VAT number is GB 206 6518 18.