Parallel Imports

Question 1

DEFINITION OF A PARALLEL IMPORT

Answer 1

• A PI is a legitimately produced medicinal product imported into one member state from another without the permission of the company who own the intellectual property rights in its country of origin
  
  • It allows a medicinal product authorised in one member state to be marketed in another provided the products have no therapeutic difference from the original

Question 2

PARALLEL IMPORTS – CONCERNS

Answer 2

• Mainstream industry
  
  • Risk to profits!
  • Attempts to limit supplies in low cost markets
    *May be illegal
  • Regulators’ concerns
  • Lack of document trail
  • Risk of confusion for patients
  • Also – makes it easier for counterfeits?

Question 3

PI – THE REGULATORY POSITION

Answer 3

• Concerns from Dutch authorities in mid 1970s
  ○ European Court of Justice
  ○ De Peijper Judgement
  
  • Proposed Directive 1980, rejected by Parliament
  • Commission Communication 6 May 1982
    ○ Adopted by all Member States
    ○ Regulatory Guidance
  • Subsequently adopted into Directive 87/21/EEC
    ○ Now incorporated into Directive 2001/83/EC
  • A PI may be obtained, through a simpler procedure than the original MA, provided that:
    ○ * Sales do not present a risk to public health
    ○ * Product has an MA in Member State of origin
• Product is sufficiently similar to a product that has already received an MA in Member State of destination

Question 4

UK PL/PI LICENCES

Answer 4

• Imported product must be therapeutically equivalent to the one already marketed in importing member state
  
  • UK Specific – Licence Categories
  • 3 Types:
    ○ Parallel Import (Simple)
    ○ Parallel Import (Standard)
    ○ Parallel Import (Complex)
  • Simple
    ○ UK product and the product to be imported from a Member State are manufactured by companies in the same group of companies or are made under licence from the same licensor. This is the traditional ‘common origin’ criterion
  • Standard
    ○ UK and imported products do not share a common origin (as defined above) and the application is not ‘Complex’
  • Complex
    ○ UK and imported products do not share a common origin (as defined above) and:
    ○ The imported product contains a new excipient
    ○ The imported product contains an active ingredient made by a different route from that used in the UK product
    ○ The imported product is a controlled release preparation
    ○ The imported product is a sterile product which is sterilised in a different way from the UK product
    ○ The imported product is a sterile product in which the container is made from a different material to the container of the UK product
    ○ The imported product is a flu vaccine
    ○ The product is a metered dose inhaler
    ○ The product is a powder for inhalation
    ○ Bioequivalence of the UK and imported product cannot be demonstrated through bioavailability studies
    ○ The sole or primary evidence for the safety and efficacy of the imported product consists of published scientific literature
    ○ The manufacturer of the active ingredient contained in the imported product is different from the manufacturer of the active ingredient contained in the UK product

Question 5

FALSIFIED MEDICINES DIRECTIVE – SAFETY FEATURES and parallel imports

Answer 5

• An MA holder who is not the original manufacturer (e.g. a parallel importer) is only permitted to remove, replace or cover the safety features under strict conditions
  
  • In the case of re‐packaging the safety features should be replaced by equivalent safety features:
  • I.e. the replacements must be equally efficient in identifying, authenticating and preventing tampering
  • QP must assure this!

Question 6

Parallel imports and OVER-LABELLING AND ASSEMBLY

Answer 6

• Original labelling/insert in foreign language
  
  • Over‐labelling/assembly
  • Labelling to be approved
  • Assembler must be licensed
  • Manufacturers Import Authorisation (MIA)
  • Contractor or Importer

Question 7

Parallel imports and QP release

Answer 7

• Often locum arrangements
  
  • Document trail non‐existent
    ○ Register of origins, quantity and batch number
    ○ Authorities require verification in “proportion of cases” – mechanism needed to obtain records
  • ‘Presumption of conformity’
    ○ Reasonable as product on the market
    ○ If not possible verification may be required
    ○ Documentation obtained via authorities
    ○ Testing of product

Question 8

PARALLEL DISTRIBUTION

Answer 8

• Centrally Authorised Products can be distributed legally throughout the EEA as MA is the same in all Member States
  
  • The EMA MUST be notified (Regulation 726/2004)
  • PLPIs are illegal if Centrally Authorised Products is available
  • Comprehensive Q&As on EMA website