Main Subject - Business

The costs and logistics of shipping from China to the UK can be intimidating for inexperienced im

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

porters who don’t know what to expect. The wide variety of shipping rates just adds to the confu

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

sion - it’s very difficult to tell what ‘reasonable’ costs actually are.

The first thing any new

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

importer needs to do is make some inquiries. Don’t forget to shop around for shipping rates befo

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

re selecting a wholesaler.

I also recommend finding out the following details when you are arran

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ging shipping:

· Is there an inland freight charge to get to from the wholesale warehous

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

to port?

· Is there a duty payable on the product?

· Are there any restriction

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

s on bringing this product to the UK?

· Request the tariff number from the shipping agen

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

t.

· Ask the shipping agent to quote you on the shipping cost, including any clearance d

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

cument costs.

· How are you going to pick up the stock once it arrives? How much will th

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

is cost?

My tips to NZ and Australian importers apply here as well: make an effort to bargain wi

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

th the wholesaler over shipping costs. If they seem unwilling, tell them that you are shopping ar

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

und to find the best deal!

After you have been trading with the wholesaler and/or shipper succes

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

sfully for some time, inquire about lower rates for frequent customers. Most won’t offer if you

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

don’t ask.

And another thing: everything imported into the UK from outside the EU is subject to

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

AT of 17.5%. This applies to everyone, not just VAT registered companies. If you aren’t VAT regi

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

stered, you will have to get a PSEUDO TURN number. Your goods won’t get clearance without one.

I

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

think that the most useful site for finding information on this topic is HM Revenue and Customs

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

ttp://www.hmrc.gov.uk. Download the PDF’s ‘Introduction to Import and Export’ and ‘Guide to Impor

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ting and Exporting: Breaking down the Barriers’, these should cover most of what you need to know

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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