As most countries using Naltrexone implant have been found an adequate way of  import and utilization  in consultation with the Ministry of Health of these countries, it is considered that other countries may also find a similar solution. It is well known that it is not a problem to import and  use unregistered  medicine as long as it's usage is under the supervision of doctors with full qualification. So, these kind of medicines are imported worldwide on regular basis of which 2 ways are the most common:

• Import for personal use based on doctors prescription. Ususally these are medicines which are not localy available , but available in developed coutries. This way is used by  patients for their personal use.
• Import of medicines which are not available comercially (in pharmacies) but necesary for individual patient or group of patients because of their unique conditions (or circumstances). This way is used by clinics and hospitals  for the needs of their patients.

In UK , this is supevised under MHRA. They have strict supervised guidelines known as SI 2005 paragraph 4, which aloves registered wholesale with import license to import and supply named hopitals and clinics with unregistered medicines under their supervision.

The pharmaceutical wholesale is obligated to keep records about : doctors name, date of delivery (import), number of delivered products, serial (batch) numbers, all posssible negative reactions ( obtained by doctors).

Doctors who use these product are obligated to make a written agreement with the patient , a future consumer of the medicine, who must be maximaly informed, oraly and in writting, about all details regards to  medicine effects  and  possible side-effects, as well as procedures during operation (intervention description , and doctor's as well as patient's obligations before and after intervention ).**** If there is a need, we can provide a sample of this document. Doctor responsibile for the patient, patient himself, and a witness (usually patient's companions - parents, relatives....) have to sign the mentioned contract before starting any treatment with unregistered medicine.

Naltrexone implant produced by GP Product Ltd, consists of well-known,  proven and  registered substances :

• Naltrexone base (at  > 99.5 purity)
• Magnesim stearate
• Triamcinolone acetonid

All these substances are registered worldwide, which also implies  non-toxicity for human use.

 Legality of import  

It is very important to understand that:

1. We talk about unregistered medicine - where "unregistered" term implies to "using not allowed without professional supervision" i.e. - not allowed for sale in Pharmacies where patient himself can buy the product. All substances contained in Naltrexone Implants are registered worldwide. 
2. We talk about a product based on the active ingredient of Naltrexone base, produced by master formula at certified pharmaceutical factory operating under GMP standards.
3. Like production of any other medicine, an unregistered medicine production is under the regular supervision of competent inspection body.
4. Each produced batch of unregistered medicines, same as registered medicines, is submitted to analitical control - control of the content and proof of the content written on the label - and must have it's Certificate of Analysis (COA).

The law defines (in most countries) :

• Agency or other organization authorized by the Ministry of health, at the  request of healthcare institutions  may aythorize an import of the  medicines which are not licensed for marketing and are intended for the treatment of particular patient or group of patients.
• Import and delivery must be caried out by a legal entity -  licensed pharmaceutical wholesale or pharmacy (hospital pharmacy).
• Quantity of imported  medicine cannot exceed the annual needs of  healthcare institution.
• Competent body or Ministry of health will control the use of imported medicines. 

Doctors around the world are using Naltrexone implants by and according to the principles of their regulation bodies or ministries.

Naltrexone implant must be, because of  it’s specificity (implant or pellet form),  used exclusively under the control of specialized physicians. Only they can control the preconditions for it’s implementation. And of course, on their approval surgeon performs the operation and care for the surgical part of procedure.

© 2016 gp-product-ltd.com