What follows is not legal advice. You may however find it useful in making an assessment about the legality of importing hepatitis c medications into your country.

Australian Medication Import Regulations

The PBS listed the new medications in March 2016 making them freely available to all Australian’s who need treatment. This is left for historical interest.

In Australia, the TGA allows for personal importation of medication and Sofosbuvir and Ledipasvir are not on the TGA list of prohibited substances.

Under the Poisons Standard a patient is allowed to possess a Schedule 4 medication, provided they are in possession of a valid prescription.

We are aware of medications being seized by customs because one of the facilities that is testing patient medication also does the tests for customs seizures. To successfully transit Australian customs the following documents are required:

  1. IATA transport documents
  2. Material Data Safety Sheets (MDSS)
  3. Certificate of authenticity
  4. Invoice (for import duty assessment)
  5. Valid Australian prescription

New Zealand Import Regulations

The New Zealand Import Regulations are easy to navigate and say that with a New Zealand prescription you can import by mail, but with an overseas prescription only personal carriage is allowed. You will find the details at Medsafe – Importing Medications.

They even have a classification engine that simply lets you type in the name of the medication and find out if you can import it and what paperwork is required. Gotta love the Kiwis – clear, concise and well organised, even if they can’t pronounce the number 6.

UK Medication Import Regulations

In the UK the Medicines and Healthcare products Regulatory Agency (MHRA) is the governing body who if you enquire will respond with a form letter like this:

There is no requirement for a member of the public to notify the MHRA of the importation of medicines for personal use and the legislation does not restrict such importation. Consequently, we do not issue any form of licence, certificate or authorisation to aid personal importation. We consider personal use to involve the use of the products by you or your immediate family or household; under such importation you must not sell or supply imported medicines onward as this would be considered placing the product onto the market.

Please note that up to a 3 month supply of a medicine is considered to be an acceptable quantity for personal use, HM Revenue and Customs can prevent importation if large quantities are being imported and/or they have suspicions that the product is not being imported for personal use. There is more information on the HM Revenue and Customs website at the link below:

https://www.gov.uk/government/organisations/hm-revenue-customs

We would also advise you to investigate whether the product(s) to be imported would be categorised as controlled substances in the UK. Controlled drugs are regulated by the Home Office under the Misuse of Drugs Act, and can require a licence to allow their entry into the UK. The Home Office have published a list (although not exhaustive) of controlled substances on their website and we would advise you to contact them directly for clarification on whether a Home Office licence is required for importation into the UK:

https://www.gov.uk/government/publications/controlled-drugs-list

If you would be posting packages containing medicines, we suggest including a copy of the prescription and/or a letter from your doctor explaining why the product(s) are required; the package should be clearly labelled on the outside stating the contents of the package and that the products are for personal use. Medicines should be kept in their original packaging and should be transported in accordance with storage conditions specified by the Manufacturer (this not only helps identify the medicines, but also helps ensure the product’s stability).

I hope you find this information useful.

Sofosbuvir, ledipasvir, daclatasvir, and ribavirin are not currently on the controlled list, although it is worth noting that this list is under review.

USA Medication Import Regulations

In the USA the FDA is one relevant authority. They have published this short summary:

http://www.fda.gov/Aboutfda/Transparency/Basics/ucm194904.htm

Which refers to this longer version:

http://www.fda.gov/ForIndustry/ImportProgram/ucm173751.htm

The DEA (Drug Enforcement Agency) is the other relevant authority and enforces Title 21 United States Code (USC) Controlled Substances Act

http://www.deadiversion.usdoj.gov/21cfr/21usc/

This legislation prohibits the import of certain items such as narcotics, but like similar legislation in other jurisdictions does not target hepatitis c medications.

Brazillian Medication Import Regulations

Individuals can import up to USD 3000,00 in drugs through the Importa Fácil mail system, without paying taxes. 

Medicatie română Regulamentele de import (Romanian Medication Import Regulations)

La sosirea coletului in tara,  destinatarul trebuie sa furnizeze firmei de curierat rapid, urmatoarele documente:

  1.  Fotocopia unui document de identitate valid;
  2.  O declaratie scrisa si semnata de catre destinatar in care trebuie specificat continutul pachetului,  utilitatea produselor,  marca, cantitatea,  pretul unitar,  valoarea totala;
  3.  Dovada platii la expeditor.  In cazul in care plata a fost facuta printr-un tert,  acesta din urma trebuie sa furnizeze destinatarului dovada platii catre expeditor.  In cazul in care suma platita de catre tert nu corespunde cu valoarea din factura,  destinatarul trebuie sa declare scris ca suma aferenta produselor importate este inclusa in dovada de plata furnizata de catre tert.
  4.  Reteta medicala standard, scrisa in limba romana, semnata si stampilata de catre medical de familie sau specialist.

Taxe aferente importului:

  • 9% TVA din valoarea coletului 
  • 2.5% taxa comision

 Plata taxelor poate fi prin transfer bancar in contul ce va fi indicat de catre firma de curierat sau in numerar in momentul livrarii coletului.

Dear Dr. Freeman,

Below you will find the Romanian customs requirements in order that the import to be approved.

As additional info, the package must include the invoice with the purchasing amount, but I think that’s an international rule.

Once the package is arrived at Romanian customs ,  the recipient must provide to the shipping company which practically intermediates the import, the following documents :

  1. A photocopy of an identity document;
  2. A declaration written in Romanian language and signed by the recipient in which should specify the parcel content,  the utility of the products,  the brand names, the quantity received, price per unit,  the total amount.
  3. The payment proof to the sender company. In case the payment was made by a third party, this must provide the proof of payment to the recipient.  If the amount payed by the third party doesn’t corrispond with the purchasing invoice, the recipient must write and sign a declaration in which must specify that the total amount includes the value of his parcel.
  4. Medical prescription into Romanian standard format signed and stamped by the GP or specialist.

After the customs process is completed, the recipient must pay:

  • 9% VAT tax from the declared customs value
  • 2,5% a commission tax from the declared customs value.

The taxes could be payed by bank transfer or cash to the delivery agent.