NP45723 Storage and Distribution of Seasonal Influenza Vaccines & Other Products

Economic operators may be excluded from this competition if they are in breach of any situation referred to in regulation 58 of the Public Contract (Scotland) Regulations 2015.

The economic operator must confirm they already have or can commit to obtain, prior to the commencement of the contract, the levels of insurance cover indicated below:

(a) Potential Contractors must possess a current valid Wholesale Distribution

Authorisation Human (WDA(H)) issued by the Medicines and Healthcare products Regulatory Agency (MHRA).

The licensed activities that are required within the WDA(H) are:

Medicinal Products

1.1 With “an authorisation” (a UK, Great Britain or Northern Ireland Marketing Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration)

1.2 Without “an authorisation” (a UK, Great Britain or Northern Ireland Marketing

Authorisation, an Article 126a authorisation, a certificate of registration or traditional herbal registration) in GB or EEA and intended for the UK market

Authorised Wholesale Distribution Operations

2.2 Holding

2.3 Supply

Medicinal products with additional requirements

3.1.3 Immunological Medicinal Products

3.3 Cold Chain Products (requiring low temperature handling)

Categories of products handled at this site

4.1 Prescription Only Medicines

4.4 Pharmacy

(b) Potential Contractors and any sub-contractor(s) must possess valid certification of BS EN ISO9001 or equivalent.

(c) Potential Contractors must have a minimum temperature controlled (2-8 degrees C) storage capacity of 320 pallets and minimum ambient temperature controlled storage capacity of 150 pallets.

(d) Potential Contractors are required to provide evidence that their organisation has taken steps to build their awareness of the climate change emergency and how they will respond.