Contract Responsible Person & Contract
Qualified Person

Please Choose from the following
Qualified Person
Responsible Person

Responsible Person & Wholesale Distribution
Authorisation Consultancy

Contract Responsible Person: Registered with the Health Products Regulatory Authority to maintain
wholesale licence to procure, hold, supply and export medicinal product. RP will compile, review and approve
documentation and system to ensure compliance with requirements

Contract Responsible Person: Registered with the Health Products Regulatory Authority to maintain wholesale licence to store and distribute medicinal product. Review documentation and system to ensure compliance with EU requirements.
• Implement and maintain Wholesale Licence and register with Health Products
• Regulatory Authority to store and distribute pharmaceutical product.
• Experience with a vast range of regulatory authorities.
• Ensure compliance with current Good Distribution Practice (cGDP) Requirements, including, but not limited to documentation control and
all stages of storage and distribution.
• Comply with Wholesale guide and ensure all the Principal Duties and Responsibilities are met.
• FQS can provide contract responsible person on a short-term basis e.g. to cover holidays, maternity/parental leaves i.e. Deputy responsible person or long-term contracts bringing experience and up-skilling staff in issue resolution.

SCOPE OF WDA MAY INCLUDE

MEDICINAL PRODUCTS

With a Marketing Authorisation in EEA countrys

Without a Marketing Authorisation in the EEA and intended for EEA market

Without a Marketing Authorisation in the EEA and intended for exportation

Authorised Wholesale Distribution Operation

(Relating to Schedule 1 of S.I. 538 of 2007, Medicinal Products (Control of Wholesale Distribution)
Regulations 2007 to 2013)

• Procurement
• (Obtaining, acquiring, purchasing or buying medicinal products from manufacturers, importers or other wholesale distributors)
• Holding
• (Storing medicinal products)
• Supply
• (All activities of providing / selling / donating medicinal products to wholesalers; pharmacists; or persons authorised or entitled to supply
medicinal products to the public)
• Export
• (All activities relating to the supply of a medicinal product to a state other than a EU Member State or a Contracting State of the European Economic Area)
• Other activities(s): (AS REQUIRED)

Categories Of Medicinal Products With
Additional Requirements

(Relating to Schedule 1 of S.I. 538 of 2007, Medicinal Products
(Control of Wholesale Distribution) Regulations 2007 to 2013)
• Products according to Art. 83 of 2001/83/EC1
o Narcotic or psychotropic products
o Medicinal products derived from blood
o Immunological medicinal products
o Radiopharmaceuticals (including radionuclide kits)
• Medicinal gases
• Cold chain products (requiring low temperature handling)
• Other products
o Prescription only medicinal products
o Medicinal products for general sale
o Over the counter medicinal products for sale through pharmacies only
o Unauthorised medicinal products (see note 1)
o Vaccines
o Parallel imported medicinal products authorised by Parallel Product Authorisation (PPA)
o Parallel imported medicinal product authorised by Dual Pack Registration (DPR)
o Parallel distributed centrally authorised medicinal products
o Traditional herbal medicinal products
o Homeopathic medicinal products (HOR and HOA)
o Exempt medicinal products (see note 2)
o Biological products
o Advance Therapeutic Medicinal products

Note 1:
Unauthorised medicinal products are products which do not hold a  marketing authorisation in Ireland. A wholesaler may supply such products only to markets outside of Ireland where the products are authorised. Unauthorised medicinal products are not for supply on the Irish market.

Note 2:
An exempt medicinal product is a medicinal product which does not hold a marketing authorisation. It is supplied in response to a bona fide unsolicited order formulated in accordance with the specification of a practitioner for use by their individual patients on their direct personal responsibility.

Note 3:
Please be aware that a separate
licence/registration is required
to wholesale
controlled drugs

Qualified Person & Manufacturer Importers
Authorisation Consultancy

Contract Qualified Person: Registered with the Health Products Regulatory Authority to release medicinal product from pharmaceutical companies for numerous markets e.g. European, Australian, Japan and American. QP will compile, review and approve documentation and system to ensure compliance with requirements.

• Contract Qualified Person: Registered with the Health
Products Regulatory Authority to release medicinal
product from pharmaceutical companies for numerous
markets e.g. European, Australian, Japan and American.
Review documentation and system to ensure compliance
with requirements.
• Implement and maintain Manufacturing Licence,
quality system and register with Health Products
Regulatory Authority to release pharmaceutical product.
• Experience as a Qualified Person with different forms
(e.g. solid dose, liquids, semi solids), contract manufacturing
and packaging, controlled drugs, developmental and clinical trials.

• Comply with Manufacturing licence, product authorisation, Annex 16 and relevant legislation and guidelines ensuring all the Principal Duties and Responsibilities are met.
• Using the knowledge of regulations, product stability and product/licence requirements, FQS ensure products are released in compliance to the systems in place. FQS supports continuous
improvements and reduces release times and deviations and increases right first time.
• FQS can provide contract qualified person on a short-term basis e.g. to cover holidays,
maternity/parental leaves or long term contracts bringing experience and up-skilling staff in issue resolution.

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