Home

  • Order to parcel locker

    Order to parcel locker

  • easy pay

    easy pay
  • Oncofertility
  • Reduced price
Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022

Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022

9780857114396
516.60 zł
490.77 zł Save 25.83 zł Tax included
Lowest price within 30 days before promotion: 490.77 zł
Quantity
Available in 4-6 weeks

  Delivery policy

Choose Paczkomat Inpost, Orlen Paczka, DPD or Poczta Polska. Click for more details

  Security policy

Pay with a quick bank transfer, payment card or cash on delivery. Click for more details

  Return policy

If you are a consumer, you can return the goods within 14 days. Click for more details

Description
The 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, known as The Orange Guide”, is the essential reference for all manufacturers and distributors of medicines in the UK.

It provides you with a single authoritative source of European and UK guidance, information and UK legislation relating to the manufacture and distribution of human medicines, active substances, and brokering medicines.

The new 11th edition has been updated to incorporate changes made after the UK’s exit from the European Union on the 31st January 2020.

Comprehensive new content includes::

Amended extracts from the Human Medicines Regulations 2012 relating to::
manufacture, importation and assembly
wholesale dealing
brokering medicine
manufacturing, importing and distributing active substances
The Code of Practice for Qualified Persons, Guidance on Manufacture and Importation
UK guidance on complying with the EU guidelines on Good Distribution Practice for wholesale distributors and brokers of medicines and manufacturers, importers and distributors or active substances
UK guidance on:: risk-based inspections, conditions of holding a manufacturer’s licence, wholesale dealer’s licence, a broker registration and an active substance registration, and controls on certain medicinal products.

New guidance on::
conditions of holding a manufacturing authorisation for investigational medicinal products,
importing guidance for investigational medicinal products from countries on a list to Great Britain,
Pharmaceutical Quality System expectations and Authorisation requirements for investigational medicinal products importation oversight,
list of approved countries for import,
pharmacovigilance for wholesalers,
the naming of sites on a wholesale dealer’s licence,
self-inspection for wholesale dealers and the responsible person for import.

Plus, revised GMP Annexes 2 and 17, and Commission guidance on principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, for medicinal products for human use and for active substances for medicinal products for human use.

The Orange Guide is compiled by the Medicines and Healthcare products Regulatory Agency.

Product Details
Pharmaceutical Press
92718
9780857114396
9780857114396

Data sheet

Publication date
2022
Issue number
1
Cover
paperback
Pages count
1140
Dimensions (mm)
1720.00 x 2440.00
You might also like
Comments (0)

  • Frequently purchased together

    No products available