Regulatory Affairs

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Regulatory Affairs

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LICENSING

As per The Human Medicines Regulation that is followed in the UK, authorisations are required at all stages for medicines meant for human use.  This includes authorisations to manufacture, import, distribution, sale and supply of medicines along with authorisations for labelling and advertising, and for Pharmacovigilance.

At Saigates Scientific Solutions, we assist our clients to complete the following licensing applications successfully.

A clinical trial of a medicinal product on human subjects under the investigation requires authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

For international trials in Europe, an application to an equivalent authority in each of the member state is mandatory. All trials must be registered on the European Clinical Trials Databases by obtaining a EudraCT number.

Saigates Scientific Solutions helps clients through the following processes from start to finish:

  • – CTA submission
  • – Ethics submission
  • – R & D submission
  • – MHRA inspection
  • – Trial Master File
  • – Integrated Research Application System (IRAS)

 

Saigates Scientific Solutions can also advise you on other stages of your trials such as:

  • – Trial Planning and Design
  • – Risk Assessment
  • – Protocol Development
  • – Trial Management & monitoring
  • – Trial Documentations
  • – Trial Supplies
  • – R&D Consultation
  • – On-going Management & Monitoring
  • – Statistical Data Analysis
  • – Clinical Trial Summary Report

According to the medicines legislation all medicinal products require a license before they are marketed in the UK. In order to get a marketing authorisation for a medicinal product in more than one Member State in the EU, client must sought to one of the following three procedures.

  • – The “Centralised Procedure”,
  • – The “Mutual Recognition Procedure” or
  • – The new “Decentralised Procedure“.

 

In addition, national authorisations allow for products to be marketed in individual countries in the EU. A product may be authorised in several Member States by a number of national authorisations, or one of these may be used as the basis for a Mutual Recognition Procedure. The regulatory agency of the country concerned has the responsibility for monitoring and assessing the safety of products with national authorization.

Centralised Procedure – This particular procedure requires to be administered by the European Medicines Agency (EMEA). It consists of a single application, which once approved, grants marketing authorisation throughout European nations. It is the responsibility of the European Commission to monitor the products, which come to the market through this centralised procedure. The procedure is available to all new, or innovative pharmaceuticals, and is obligatory for biotechnology medicines. It is mostly used for products containing new substances for which the therapeutic indication is the treatment of a specific disease.

Saigates Scientific Solutions helps clients with the above application to the EMA, which will appoint the regulatory agency of a member state as Rapporteur, which will further carry out initial assessment of the application for Marketing Authorisation.

Mutual Recognition Procedure – This is a convenient route to get marketing authorisation in other Member States, if you hold a marketing authorisation of the same product in one Member State. Here, the Member State where you already hold a license acts as a Reference Member State (RMS). This is “mutually recognised” by other Concerned Member States (CMS). There is a 90-day assessment period after which Member States grant a marketing authorisation with an identical summary of product characteristics to that in the Reference Member State, provided that they accept the assessment of the product.

Saigates Scientific Solutions can help you make a new application to the EMA. We also update our clients on the application by coordinating with the regulators.

Decentralised Procedure – If you do not already hold marketing authorisation (MA) in any of the Member State then SSS can prepare and submit identical dossiers in all the Members States. The process involves the reference member state preparing a preliminary assessment report and sending it to the concerned member state.

Book an appointment.

Saigates Scientific Solutions can make an application on your behalf to change any aspect of the labelling of an authorized medicinal product i.e. summary of product characteristics (SMPCs) and patient information leaflet (PIL).

Saigates Scientific Solutions can help with your Licensing Renewals by complying with the guidelines given in the Centralised and Mutual Recognition/ Decentralised Procedure.

We have the expertise to prepare the application by complying with the guidelines stated in the new legislations:

  • – Cover letter and application form
  • – List of all post-authorisation submissions since authorisation/last renewal
  • – Any follow up measures as may be necessary
  • – Certificate of compliance with GMP and QP declaration that the active substance is manufactured in accordance with GMP
  • – PIL, SPC and packaging and labelling information
  • – Quality overview
  • – Clinical overview
  • – Reports of post-marketing experience (PSURs)
  • – SPC, labelling and patient information leaflet in word format

We will submit the application in EU CTD format.

While making the licensing submissions, it is extremely important to submit the application in a correct form. Your application might get delayed or even rejected if the information supplied is not put in a correct order. Out years of experience at Saigates Scientific Solutions can help you prepare a winning electronic common technical document (eCTD), which is highly recommended for making the Marketing Authorisation Applications (MAAs).

Saigates specialises in creating the eCTD for electronic submissions. We are an experts in creating new Marketing Authorisation Applications (MAAs) and variation applications.

As per the new requirements, Saigates Scientific Solutions will make and manage your electronic submission with all the documents in PDF format for National, MR or Decentralised procedure including:

  • – Market authorisation application form.
  • – Supporting data files – named correctly (see below) with one PDF file for each CTD document.
  • – The SmPC prepared and sent using the MHRA Microsoft Word template

For the variation applications, Saigates Scientific Solutions will submit all the application forms in PDF format with one PDF file for each document, including:

  • – Adobe PDF Variation application form.
  • – New or replacement data files – named correctly with one PDF file for each CTD document.
  • – Variations to the SmPC should be accompanied by the appropriate section(s) of the SmPC submitted as individual Word fragments (see File Formats section above).

Saigates Scientific Solutions has expertise that helps our clients submit ASMF for a new application, in PDF format with one PDF file for each document named below, as per the new requirements:

For new applications the following documents are mandatory:

  • –  Cover letter
  • –  Applicants part
  • –  Restricted part
  • –  Quality overall summary
  • –  Letter of access

A company wanting to warehouse and distribute pharmaceutical products in the UK must apply for a wholesale dealer authorisation (WDA) previously known as wholesale dealers licence (WDL).

In order to gain a wholesale dealers authorisation (WDA), the holder must comply with specific regulation guidelines in relation to wholesale distribution of relevant medicinal products. Here at Saigates Scientific Solutions we can help assess business to meet these regulation guidelines.

The Medicines and Healthcare products Regulatory Agency (MHRA) will inspect your pharmacy to ensure it has the relevant processes in place for storage and distribution facilities, training and Standard Operating Procedures (SOPs) that cover all the aspects of the Good Distribution Practice (GDP) guidelines.

GDP guidelines are to ensure an efficient and compliant distribution of pharmaceuticals i.e. all products must be consistently stored, transported and handled under suitable conditions as required on the product specifications.

The MHRA is constantly raising their standards on GDP. We assist our clients to ensure processes are up to the standards required prior to the GDP inspections. GDP inspection is an important part of the MHRA’s remit and a timetable of inspections are set as part of each wholesale dealers authorisation (WDA). We will not only help you make a successful application, but also advice you on how to prepare for the inspection by the Medicines Inspectorate.