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  • Advice Pool - Amending Law of Evidence (Qunun-e-Shahadat Order 1984) and e-Taxation

    Although the Electronic transaction ordinance 2002 has made amendments in Qunun-e-Shahadat to meet basic criterion of evidence regarding electronic transaction, like Article 2 regarding
    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
    admission; Article 49-A acceptance of relevance of information generated by automated information system; Article 59 Expert opinion of information technology officer; Article 73 regardin
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    g acceptance of primary evidence of any information received and transmitted in computer based form out of automatic generated transaction and also Article 78-A prove of digital signatur
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    e.

    These amendments the article 184 of Qunun-e-Shahadat have also widened the definition evidence to include “scientific devices” produced thereby modern devices, although the definitio
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    n of “modern” device has been extended to video films but no statutory amendments have been made regarding the extension of evidential definition to include e-commerce transaction expert
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    opinion.

    With these amendments it different to suppose rather these amendments will lead to smooth running of legal system. How the automated generated information will be place before
    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
    court, either server side or client side response? Who is going to be an expert? Rather the power of expert has been defined; rather he has been granted the right to hack the security r
    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
    ights of system? What is a basic standard and criterion for an expert? Evidence, whether these are contained in documents or recorded through oral evidence, must be admissible before
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    a court. Certain admissible evidence carries more evidential weight or value than others. In terms of the rules of evidence, the admissibility or evidential weight of evidence would dep
    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
    end on whether the "best evidence" thereof had been presented to the court.

    In common law countries verbal evidence takes a strong precedence over other forms of evidence, such evidence
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    can only be admitted, however, if it comes from the person who had direct knowledge of the matter he exposes. Therefore, according to the "Hearsay Evidence Rule", a document cannot be u
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    sed as evidence if its author does not witness it. In recent years a number of provisions were introduced into Qunun-e-shahdat in order to address the hearsay evidence rule as it effects
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    computer generated evidence. Broadly, these provisions were designed to allow a court to admit computer evidence even though it was hearsay.

    Article of 78-A of Qunun-e-Shahadat, proof
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    of Electronic signature has been amended by promulgation Electronic Transaction Ordinance 2002, but complex issues can not resolved by amendment in one article, we need here to promulgat
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    e detail digital signature laws for purposes of just adjudication of e-commerce taxation.

    All transaction in e-commerce is made by acceptance of terms and conditions by Client imposed b
    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
    y Website operators by pressing acceptance button, by doing that he undergoes legal obligation by accepting terms and conditions imposed on him. The aim of digital signature laws to regu
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    late website terms and conditions of contract and to impose restrict on any terms which are void or illegal according to the contract laws.

    Pakistani law, at present, with few exception
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    s treats computer records as hearsay evidence. There is, currently, no general legislation which has adopted the rules of evidence, particularly the rule against hearsay, to take account
    .

    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
    of computer technology. All businesses would face this issue in seeking to enforce contracts entered into over the internet under Pakistani law. If Pakistan is to become a hub for e-com
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    merce, priority needs to be given to updating the laws of evidence to enable businesses and Government Departments to transact business over the internet in a climate of legal stability.


    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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