27 11, 2023

Trials or Post-Brexit Imperative: A Guide to Successful UK-EU Clinical Trials Compliance

By |2023-11-27T13:28:37+00:00November 27th, 2023|Featured|

Achieving success in a UK-EU clinical trial requires the implementation of effective strategies for the release of Investigational Medicinal Products (IMPs), demanding careful planning and strict adherence to regulatory standards. The management of IMPs in trials spanning multiple jurisdictions is intricate, with the MHRA and EMA holding pivotal positions. MIAS Pharma, dedicated to serving Ireland

3 11, 2023

How would an Auditor qualify a warehouse provider to ensure they are in compliance with Annex 21?

By |2023-11-03T14:45:38+00:00November 3rd, 2023|Featured|

Annex 21 of the Good Manufacturing Practice (GMP) guidelines for medicinal products outlines the requirements for the importation of medicinal products into the European Union (EU). Warehouse providers involved in storing and handling medicinal products for importation must comply with these guidelines. To qualify a warehouse provider and ensure they are in compliance with Annex

1 11, 2023

How would a Physical Site of Importation (SOI) handle customs clearance?

By |2023-12-11T17:03:47+00:00November 1st, 2023|Featured|

A Physical Site of Importation (SOI) in the pharmaceutical industry plays a crucial role in handling customs clearance for pharmaceutical products. Customs clearance involves complying with customs regulations and procedures to facilitate the lawful entry of imported pharmaceuticals into a country. Here's how a SOI typically handles customs clearance: Documentation Preparation: Gather all required documentation

23 10, 2023

Behind the Scenes: Exploring the Crucial Role of Importation Sites in Medicinal Supply Chains

By |2023-10-23T13:49:54+01:00October 23rd, 2023|Featured|

The Physical Site of Importation (SOI) plays a pivotal role in the pharmaceutical industry. It ensures Regulatory Compliance, upholding stringent EU/EEA standards. Additionally, SOIs enable Quality Assurance through critical physical inspections, guaranteeing the safety and efficacy of imported medicines. They serve as the final destination for batch certification by Qualified Persons (QPs) and act as

29 09, 2023

Function of the RP (Responsible Person)

By |2023-09-27T15:36:59+01:00September 29th, 2023|Featured|

The function of the Responsible Person (RP) in the context of pharmaceutical wholesale distribution, as outlined by Good Distribution Practice (GDP) guidelines, is to ensure the integrity, safety, and quality of pharmaceutical products throughout the entire distribution process. The RP plays a critical role in maintaining compliance with regulatory requirements and safeguarding public health. Here

28 09, 2023

The Role of GDP in preventing falsified Medicines

By |2023-09-27T15:36:28+01:00September 28th, 2023|Featured|

The function of the Responsible Person (RP) in the context of pharmaceutical wholesale distribution, as outlined by Good Distribution Practice (GDP) plays a crucial role in preventing falsified medicines from entering the legitimate pharmaceutical supply chain. Falsified medicines are counterfeit or substandard drugs that can pose serious risks to patient health. Here's how GDP contributes

27 09, 2023

UK Requirements for a RP to be on a Wholesale Distribution Authorisation (WDA)

By |2023-09-27T14:50:12+01:00September 27th, 2023|Featured|

The Responsible Person (RP) on a UK Wholesale Distribution Authorisation (WDA) for pharmaceuticals has specific responsibilities to ensure that imported pharmaceutical products are distributed in compliance with Good Distribution Practice (GDP) and regulatory requirements. Here are the key requirements and responsibilities for the RP on a UK WDA: Qualifications and Experience: The RP must have

30 08, 2023

ATMPs and why you should use MIAS Pharma as your Batch Certification partner of choice

By |2023-09-03T21:45:53+01:00August 30th, 2023|Featured|

Advanced therapy medicinal products ( (ATMPs) are medicines that are based on genes, tissues or cells which offer groundbreaking new opportunities for the treatment of disease and injury. ATMPs can be classified into three main types:   Gene therapy medicines: these contain genes that lead to a therapeutic, prophylactic or diagnostic effect. They work by inserting 'recombinant'

29 08, 2023

Key differences between ATMPs and other complex products

By |2023-08-29T15:40:00+01:00August 29th, 2023|Featured|

Advanced Therapy Medicinal Products (ATMPs) are a category of innovative medical products that includes gene therapies, cell therapies, and tissue-engineered products. These therapies are designed to treat or potentially cure diseases by using advanced technologies to manipulate the patient's genes, cells, or tissues. Comparing ATMPs to other complex products, such as traditional small molecule drugs

23 08, 2023

ATMP’s as the future of Personalised Medicine

By |2023-08-23T15:42:28+01:00August 23rd, 2023|Featured|

Advanced Therapy Medicinal Products (ATMPs) hold significant promise in shaping the future of personalised medicine. Personalised medicine aims to provide medical treatments and interventions tailored to the individual characteristics of each patient. ATMPs, which include gene therapies, cell therapies, and tissue-engineered products, are particularly well-suited to fulfill this vision due to their unique attributes: Individualised

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