LATEST NEWS

November 20,2015
Electronic Application Forms

From January 2016, an electronic application form (eAF) will become mandatory for all EU procedures (human and veterinary).

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Contact EMRC

Unit 5
Rath Cross Business Park
Ashbourne
Co. Meath

Phone: 00-353-1-8352818
Fax: 00-353-1-8352821
E-mail: emrc@emrc.ie

OUR SERVICES

EMRC offers professional advice and assistance in the following areas:

Pharmaceutical Regulatory Affairs

  • National and European Mutual Recognition and Decentralised Marketing Authorisation Applications - from compilation through to completion/approval
  • PA and MA renewal applications
  • Variations and Maintenance of Marketing Authorisations
  • Preparation of Medicinal Product Labels and Patient Information Leaflets (PIL’s) in line with Title V of EU Directive 2001/83/EC (as amended) using EMEA QRD templates
  • Review of compliance with Braille requirements on Pharmaceutical Packaging
  • Conducting market compliance audits incorporating the activities of Regulatory Affairs, Sales and Marketing and Quality Assurance to ensure compliance with required quality management systems, regulations and registered files
  • CTD Dossier conversion

 Wholesale and Manufacturing Services

  • Submission of licence applications, renewals and amendments
  • Quality control-organisation and advice
  • Quality Assurance Training on all aspects of a quality system including training, documentation control, change control, pharmacovigilance and complaints, corrective and preventive action plan
  • Qualified Person services
  • Responsible Person services
  • Compliance training and review of procedures for grocery wholesalers handling medicinal products in line with current guidelines and regulatory requirements
  • Compliance training and review of procedures for cosmetics wholesalers in line with current guidelines and regulatory requirements
  • Compliance training and review of procedures for medical device wholesalers in line with current guidelines and regulatory requirements
  • Third country importation of medicinal products
  • Exempt medicinal product handling and compliance with regulatory requirements

 Medical Devices

  • Medical device registration
  • CE marking
  • Liaison with Notified Bodies/Competent Authorities 

 Food Supplements and Cosmetics

 Food Supplements

  • Interpretation of legislation in relation to food supplements
  • Reviewing Food supplement labels/advertising for compliance with regulations
  • Review of ingredients and Recommended Daily Allowances against Directive Schedules
  • Notification to the Food Safety Authority of Ireland (FSAI) of intention to launch a food supplement onto the market

Cosmetics

  • Interpretation of legislation, as it relates to cosmetic products
  • Reviewing cosmetic product labelling for compliance with the Directive
  • Review of ingredients against published Directive schedules
  • Assessment of marketing and promotional material to ensure compliance
  • Compilation and/or Technical review of Product Information Files (PIFs)
  • Registration of cosmetic products of the Cosmetic Products Notification Portal (CPNP)

 Other services include:

  • Product Datasheet, Summary of Product Characteristics (SmPC), Labelling, Patient Information Leaflet and Promotional Material Preparation in line with current guidelines and regulatory requirements
  • Compliance check on all medical information and promotional material
  • Review of Ingredients, Classification and Registration of Homeopathic and Herbal Medicinal Products in compliance with current legislation
  • Training courses in Regulatory Affairs for PA holders, distributors, agents and manufacturers
  • Information service: regulations, medicinal products, market analysis